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Updated: May 2, 2022 6:03 PM
3 weeks ago
Royal Philips (NYSE: PHG, AEX: PHIA), today announced that its subsidiary Philips Respironics is notifying customers of its V60/V60 Plus and V680 ventilators about a potential issue with the electrical circuit in these ventilators that controls the 35V power supply to the ventilator and alarm. Philips Respironics... has identified that there is a possibility that affected ventilator units may cease to operate, potentially without setting off an audible/visual alarm (a so-called silent shutdown), and the patient may no longer receive respiratory assistance.
Philips Respironics projects an average of less than one silent shutdown among one million uses per year. Philips Respironics is advising customers that they must implement one or more of the following actions to mitigate the rare possibility of the hazard caused by the 35V electric circuit issue:
- Implement an oxygen analyzer with appropriate alarm settings for each V60/V60 Plus, or V680; and/or
- Connect the V60/V60 Plus or V680 to a nurse call/remote alarm system, as documented in the instructions for use; upon request, Philips Respironics can provide technical assistance to implement this nurse call/remote alarm capability; and/or
- Monitor the patient with pulse oximetry or other physiological monitoring appropriate to the institution’s capabilities and patient needs.
- An alternative means of ventilation should be available whenever the V60/V60 Plus or V680 ventilator is in use. If a fault is detected in the ventilator, disconnect the patient from it and immediately start ventilation with such an alternative device. The ventilator must be removed from clinical use and serviced by authorized service personnel.
If these mitigations are not available, Philips Respironics recommends each institution deliberately make a decision that balances the risks and benefits of continued use of the V60/V60 Plus and V680 against the risks and benefits of ceasing use and/or substituting other ventilators. Such decision-making should consider the institution’s capabilities and patient needs.
Philips Respironics is committed to addressing the issue and will provide regular updates to customers on the development of its plan to address the issue, with the first update to be provided before June 30, 2022. The V60/V60 Plus is not a life support ventilator. It is an assist ventilator and is intended to augment patient breathing. The V680 ventilator provides invasive and non-invasive respiratory support. The V60/V60 Plus and V680 ventilators are not authorized for use in a home or non-institutional setting.
Company name: Philips Respironics
Brand name: Philips Respironics
Product recalled: V60/V60 Plus, and V680
Reason of the recall: A potential issue with the electrical circuit in these ventilators that controls the 35V power supply to the ventilator and alarm
FDA Recall date: May 02, 2022
Family Dollar Drugs, Medical Devices, Cosmetics, & Food products - recalled due to Salmonella and rodent contamination, USA
3 months ago
Family Dollar, Inc. is initiating a voluntary retail level product recall of certain products regulated by the U.S. Food and Drug Administration (FDA) that were stored and shipped to 404 stores from Family Dollar Distribution Center 202 in West Memphis, Arkansas from January 1, 2021 through the... present due to the presence of rodents and rodent activity at Family Dollar Distribution Center 202. To date, Family Dollar is not aware of any consumer complaints or reports of illness related to this recall.
There are numerous hazards associated with rodents including the potential presence of Salmonella. Use or consumption of affected products may present risk of illness due to the potential presence of Salmonella, an organism which can cause serious and sometimes fatal infections in infants, young children, frail or elderly people, pregnant persons, persons with pre- existent pathology (e.g., patients with cancer undergoing chemotherapy treatments, organ transplant recipient, etc.) and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.
Products covered by this retail level recall include all: (i) drugs; (ii) medical devices; (iii) cosmetics; (iv) dietary supplements; and (v) human and animal (pet) food products. The recall does not apply to products shipped directly to the stores by the distributor or manufacturer, such as all frozen and refrigerated items. The 404 stores to which this recall applies are listed below. The recall does not apply to other store locations.
Family Dollar is notifying its affected stores by letter asking them to check their stock immediately and to quarantine and discontinue the sale of any affected product. Customers that may have bought affected products may return such products to the Family Dollar store where they were purchased without receipt.
Customers with questions regarding this recall may contact Family Dollar Customer Service at 844-636-7687 between 9am and 5pm EST. Customers should contact their physician or health care provider if they have experienced any problems that may be related to using these products. Customers with concerns about their pets who have eaten the recalled animal food products should contact their veterinarian.
Check the full recall details on fda.gov
Company name: Family Dollar, Inc.
Brand name: Numerous brand names
Product recalled: Numerous human food, animal (pet) food, medical devices, and drug products
Reason of the recall: Potential Salmonella contamination and presence of rodent activity at the distribution center
FDA Recall date: February 18, 2022
Affected Stores by State
- Store #567. 35 MEMORIAL PKY E. ALICEVILLE, AL. 35442-2155
- Store #12825. 15704 AL HIGHWAY 216. BROOKWOOD, AL. 35444
- Store #12505. 206 GREENSBORO STREET. EUTAW, AL. 35462
- Store #868. 303 S. MAIN ST.. LINDEN, AL. 36748-1725
- Store #9012. 1307 NORTH WASHINGTON STREET. LIVINGSTON, AL. 35470
- Store #8919. P O BOX 308. MOUNDVILLE, AL. 35474
- Store #12506. 5705 US HIGHWAY 278. SULLIGENT, AL. 35586
- Store #639. 524 14TH ST. TUSCALOOSA, AL. 35401-3434
- Store #3812. 1507 CULVER RD. TUSCALOOSA, AL. 35401-2632
- Store #10460. 2515 MARTIN LUTHER KING JR BLV. TUSCALOOSA, AL. 35401
- Store #11726. 3851 GREENSBORO AVENUE. TUSCALOOSA, AL. 35405-2846
- Store #12679. 1525 SKYLAND BLVD EAST. TUSCALOOSA, AL. 35405-4231
- Store #2714. 9598 HIGHWAY 18. VERNON, AL. 35592-1527
- Store #9013. 700 4TH AVENUE. YORK, AL. 36925
- Store #11135. 1550 PINE STREET. ARKADELPHIA, AR. 71923
- Store #8376. 603 NORTH CHURCH ST.. ATKINS, AR. 72823
- Store #985. 1275 E MAIN ST. BATESVILLE, AR. 72501-3018
- Store #4378. 2001 W MAIN ST. BLYTHEVILLE, AR. 72315-3033
- Store #4239. 1421 PINECREST STREET. BRINKLEY, AR. 72021-0000
- Store #11116. 1302 S PINE STREET. CABOT, AR. 72023-3812
- Store #1197. 216 CALIFORNIA AVENUE. CAMDEN, AR. 71701
- Store #4154. 300 MADISON ST. CLARENDON, AR. 72029-2718
- Store #6613. P.O. BOX 265. CLARKSVILLE, AR. 72830
- Store #1068. 254 OAK ST. CONWAY, AR. 72032
- Store #2899. 308 C PINE STREET. CROSSETT, AR. 71635-2910
- Store #9296. 301 E 8TH STREET. DANVILLE, AR. 72833
- Store #10410. 205 E SPEEDWAY STREET. DERMOTT, AR. 71638
- Store #12661. 1602 MAIN STREET. DES ARC, AR. 72040-3116
- Store #601. 300 S. WHITEHEAD DRIVE. DEWITT, AR. 72042
- Store #11229. 439 E CHOCTAW STREET. DUMAS, AR. 71639-2319
- Store #2994. 17668 US HIGHWAY 64. EARLE, AR. 72331
- Store #1467. 424 N WEST AVE. EL DORADO, AR. 71730-5938
- Store #4396. 1005 E FORDYCE ST. ENGLAND, AR. 72046-1417
- Store #3026. 2963 S HWY 65. EUDORA, AR. 71640
- Store #1048. 1007 W 4TH ST. FORDYCE, AR. 71742-2217
- Store #4112. 228 W BROADWAY ST. FORREST CITY, AR. 72335
- Store #3278. 802 E MAIN ST STE 1. GREEN FOREST, AR. 72638
- Store #10609. 506 E. MAIN ST.. GURDON, AR. 71743-1244
- Store #13122. 700 N MAIN STREET. HAMBURG, AR. 71646-2718
- Store #11148. 214 S LEE STREET. HAMPTON, AR. 71744
- Store #4251. 608 N ILLINOIS ST. HARRISBURG, AR. 72432-1248
- Store #1526. 640 MALVERN AVE. HOT SPRINGS, AR. 71901-5432
- Store #3261. 3339 CENTRAL AVE. HOT SPRINGS, AR. 71913-6279
- Store #6016. 899 PARK AVE. HOT SPRINGS, AR. 71901-3004
- Store #8473. 3242 ALBERT PIKE RD. HOT SPRINGS, AR. 71913
- Store #5598. 1700 S HIGHWAY 161. JACKSONVILLE, AR. 72076-5509
- Store #3527. 106 S GEE ST. JONESBORO, AR. 72403-2519
- Store #12892. 1218 N HIGHWAY65. LAKE VILLAGE, AR. 71653-7563
- Store #12823. 325 W BROAD STREET. LEPANTO, AR. 72354-2203
- Store #708. 801 E. ROOSEVELT ROAD. LITTLE ROCK, AR. 72206-2410
- Store #1314. 4514 W 12TH ST. LITTLE ROCK, AR. 72204-1924
- Store #1478. 3500 BASELINE ROAD. LITTLE ROCK, AR. 72209
- Store #2769. 8824 GEYER SPRINGS RD. LITTLE ROCK, AR. 72209-4701
- Store #3632. 3901 S UNIVERSITY AVE. LITTLE ROCK, AR. 72204-7832
- Store #3762. 20290 ARCH ST. LITTLE ROCK, AR. 72206-9217
- Store #4825. 1711 MAIN ST. LITTLE ROCK, AR. 72206-1471
- Store #5771. 8510 COLONEL GLENN RD. LITTLE ROCK, AR. 72204-8229
- Store #7191. 5200 WEST 65TH ST. LITTLE ROCK, AR. 72209-3818
- Store #8936. 10422 CHICOT ROAD. LITTLE ROCK, AR. 72209
- Store #11390. 2408 DR MARTIN LUTHER KING JR. LITTLE ROCK, AR. 77206-2079
- Store #9371. 404 E PAGE AVENUE. MALVERN, AR. 72104
- Store #1037. 286 W CHESTNUT ST. MARIANNA, AR. 72360-2132
- Store #2295. 138 BLOCK ST. MARION, AR. 72364-1956
- Store #10820. P.O. BOX 65. MARVELL, AR. 72366
- Store #12712. 652 HIGHWAY 365. MAYFLOWER, AR. 72106-9630
- Store #602. 606 HOLLY STREET. MCGEHEE, AR. 71654
- Store #12754. 609 E MAIN STREET. MELBOURNE, AR. 72556-8031
- Store #11091. 620 W GAINES STREET. MONTICELLO, AR. 71655
- Store #12749. 1313 E BROADWAY. MORRILTON, AR. 72110
- Store #741. 2633 PIKE AVE. N LITTLE ROCK, AR. 72114-1926
- Store #1921. 4149 E BROADWAY ST. N LITTLE ROCK, AR. 72117-4120
- Store #6314. 4204 CAMP ROBINSON RD. N LITTLE ROCK, AR. 72118-4610
- Store #10170. 2121 HIGHWAY 161. N LITTLE ROCK, AR. 72117-3707
- Store #10531. 715 E BROADWAY STREET. N LITTLE ROCK, AR. 72114-5764
- Store #5472. 4143 JOHN F. KENNEDY BLVD. NORTH LITTLE ROCK, AR. 72116-8264
- Store #12112. 5613 MACARTHUR DRIVE. NORTH LITTLE ROCK, AR. 72118
- Store #12842. 1051 W KEISER. OSCEOLA, AR. 72370-2914
- Store #1109. 300 W KINGS HIGHWAY. PARAGOULD, AR. 72450-4229
- Store #2436. 416 S FOURCHE AVE. PERRYVILLE, AR. 72126-8005
- Store #1105. 2801 S OLIVE ST. PINE BLUFF, AR. 71603-5439
- Store #3782. 5316 DOLLARWAY RD. PINE BLUFF, AR. 71602-4013
- Store #4955. 1113 S BLAKE ST. PINE BLUFF, AR. 71603-2315
- Store #5604. 3100 W 28TH AVE. PINE BLUFF, AR. 71603-4805
- Store #8153. 1607 E HARDING AVE.. PINE BLUFF, AR. 71601-6823
- Store #11882. 1169 W 16TH AVE. PINE BLUFF, AR. 71603
- Store #4153. 2104 HIGHWAY 62 W. POCAHONTAS, AR. 72455-3640
- Store #4009. 1200 S KNOXVILLE AVE. RUSSELLVILLE, AR. 72802-6401
- Store #2686. 2223 W BEEBE CAPPS EXPY. SEARCY, AR. 72143-5018
- Store #12562. 601 S LINCOLN. STAR CITY, AR. 71667
- Store #8952. 1823 S. MAIN STREET. STUTTGART, AR. 72160-6012
- Store #2096. 443 HIGHWAY 463 S. TRUMANN, AR. 72472
- Store #12780. 10 EAGLE STREET. VILONIA, AR. 72173
- Store #3956. 500 SW FRONT ST. WALNUT RIDGE, AR. 72476-2637
- Store #1256. 317 S MARTIN ST. WARREN, AR. 71671-2817
- Store #1294. 233 N SEBASTIAN ST. WEST HELENA, AR. 72390-2447
- Store #785. 2113 E BROADWAY ST. WEST MEMPHIS, AR. 72301-3454
- Store #3180. 209 SHOPPINGWAY BLVD STE B. WEST MEMPHIS, AR. 72301-1733
- Store #11802. 420 S AVALON STREET. WEST MEMPHIS, AR. 72301
- Store #798. P O BOX 591. WYNNE, AR. 72396-0591
- Store #906. 232 BOLTON AVE. ALEXANDRIA, LA. 71301-7126
- Store #6568. 2501 3RD ST. ALEXANDRIA, LA. 71302-6102
- Store #8397. 1801 HAZEL ST. ARCADIA, LA. 71001-4131
- Store #10819. 1022 COTEAU RODAIRE HIGHWAY. ARNAUDVILLE, LA. 70512
- Store #749. 810 MAIN ST. BAKER, LA. 70714-3442
- Store #917. 542 N WASHINGTON ST. BASTROP, LA. 71220-3040
- Store #6150. 1714 E MADISON AVE. BASTROP, LA. 71220-4032
- Store #11090. 8027 SCENIC HIGHWAY. BATON ROUGE, LA. 70807-4926
- Store #11753. 6910 MICKENS ROAD. BATON ROUGE, LA. 70811-5937
- Store #10832. 60 WEST 4TH STREET. BERNICE, LA. 71222
- Store #3542. 904 REES ST STE B. BREAUX BRIDGE, LA. 70517-4514
- Store #4432. P.O. BOX 308. BREAUX BRIDGE, LA. 70517
- Store #11871. 3047 GRAND POINT HIGHWAY. BREAUX BRIDGE, LA. 70517
- Store #12005. 1802 ANSE BROUSSARD HWY. BREAUX BRIDGE, LA. 70517
- Store #707. 816 NW MAIN ST. BUNKIE, LA. 71322-1644
- Store #7631. 161 HIGHWAY 80 EAST. CALHOUN, LA. 71225-9147
- Store #877. 631 VETERANS MEMORIAL DRIVE. CARENCRO, LA. 70520-3620
- Store #9337. P.O. BOX 537. CARENCRO, LA. 70520
- Store #11174. 2405 HWY 93. CARENCRO, LA. 70520
- Store #12829. 1045 HIGHWAY 107. CENTER POINT, LA. 71323
- Store #8256. 1234 HWY 4. CHATHAM, LA. 71226
- Store #2562. 336 S. MAIN STREET. CHURCH POINT, LA. 70525
- Store #5417. 9203 HWY 67. CLINTON, LA. 70722
- Store #1852. 7741 HWY 165. COLUMBIA, LA. 71418-3323
- Store #5365. 409 CHOUPIQUE LN. COTTONPORT, LA. 71327-3737
- Store #8495. 807 BROADWAY DR.. DELHI, LA. 71232
- Store #12463. 12905 LA 28 EAST. DEVILLE, LA. 71328
- Store #5281. 505 S MAIN ST. FARMERVILLE, LA. 71241-3215
- Store #664. 504 E WALLACE RD. FERRIDAY, LA. 71334-3223
- Store #8482. 6194 HIGHWAY 10. GREENSBURG, LA. 70441
- Store #12194. 707 HWY 8. HARRISONBURG, LA. 71340
- Store #2596. 3000 HIGHWAY 10. JACKSON, LA. 70748-1409
- Store #8568. 448 OLD WINNFIELD RD. JONESBORO, LA. 71251-3855
- Store #650. 1904 4TH STREET. JONESVILLE, LA. 71343
- Store #5732. 512 AVENUE G. KENTWOOD, LA. 70444-2726
- Store #1126. 2009 W UNIVERSITY AVE. LAFAYETTE, LA. 70506-2576
- Store #1714. 107 CARMEL AVE. LAFAYETTE, LA. 70501-5001
- Store #2766. 2228 AMBASSADOR CAFFERY PKY. LAFAYETTE, LA. 70506-3705
- Store #4746. 1100 W WILLOW ST. LAFAYETTE, LA. 70501-1779
- Store #7526. 3550 W PINHOOK RD. LAFAYETTE, LA. 70508-3607
- Store #10333. 4301 MOSS ROAD. LAFAYETTE, LA. 70507
- Store #11563. 501 E PINHOOK ROAD. LAFAYETTE, LA. 70501
- Store #11630. 3841 W CONGRESS STREET. LAFAYETTE, LA. 70506
- Store #11808. 1944 MOSS STREET. LAFAYETTE, LA. 70501-2118
- Store #649. 300 SPARROW ST. LAKE PROVIDENCE, LA. 71254-3034
- Store #11404. 10251 PREJEAN HIGHWAY. LAWTELL, LA. 70550
- Store #4096. 8389 HWY 190 SE. LIVONIA, LA. 70755
- Store #5221. P O BOX 6. MANSURA, LA. 71350-0006
- Store #941. 355 W TUNICA DR. MARKSVILLE, LA. 71351-2605
- Store #834. 1421 WINNSBORO RD. MONROE, LA. 71202-4523
- Store #1262. 3038 DESIARD ST. MONROE, LA. 71201-7210
- Store #3003. 7916 DESIARD ST. MONROE, LA. 71203-4936
- Store #4788. 3390 STERLINGTON RD. MONROE, LA. 71203-2522
- Store #7850. 1420 HOSPITAL ROAD. NEW ROADS, LA. 70760
- Store #11251. 401 ELM STREET. NEW ROADS, LA. 70760-3001
- Store #12784. 1106 VERONA STREET. NEWELLTON, LA. 71357
- Store #8736. 310 WEST MAIN STREET. OAK GROVE, LA. 71263
- Store #813. 209 NATCHEZ BLVD. OPELOUSAS, LA. 70570-6524
- Store #3133. 933 CRESSWELL LN. OPELOUSAS, LA. 70570-5819
- Store #5033. 718 S UNION ST. OPELOUSAS, LA. 70570-6028
- Store #5892. 1322 W LANDRY ST. OPELOUSAS, LA. 70570-3455
- Store #11788. 8311 HIGHWAY 71 N. PINEVILLE, LA. 71360-2752
- Store #12405. 8016 RIDGE STREET. POLLOCK, LA. 71467
- Store #11324. 12902 HIGHWAY 190 W. PORT ALLEN, LA. 70767
- Store #4831. 17491 HIGHWAY 190. PORT BARRE, LA. 70577-5126
- Store #3936. 1910 JULIA STREET. RAYVILLE, LA. 71269-5516
- Store #5006. 3296 HWY 165 SOUTH. RICHWOOD, LA. 71202
- Store #11596. 2610 RICHWOOD ROAD 2. RICHWOOD, LA. 71202
- Store #8007. 612 S MONROE ST. RUSTON, LA. 71270
- Store #11435. 601 E GEORGIA AVENUE. RUSTON, LA. 71270-3930
- Store #5581. 5620 CAMERON ST. SCOTT, LA. 70583-5200
- Store #11622. 1061 RENAUD DRIVE. SCOTT, LA. 70583
- Store #12171. 9447 HIGHWAY 80. SIMSBORO, LA. 71275-3002
- Store #12863. 1101 PLANK RD. ST. JOSEPH, LA. 71366
- Store #9032. 10008 HIGHWAY 165 N. STERLINGTON, LA. 71280
- Store #5020. 122 OAK TREE PARK DR. SUNSET, LA. 70584
- Store #717. 300 N CHESTNUT ST. TALLULAH, LA. 71282-3712
- Store #670. 1919 CARTER ST.. VIDALIA, LA. 71373
- Store #4433. 710 W MAIN ST. VILLE PLATTE, LA. 70586-4326
- Store #5470. 553 VETERANS BLVD. WASHINGTON, LA. 70589
- Store #835. 117 SMITH ST. WEST MONROE, LA. 71292-6046
- Store #5335. 1202 CYPRESS ST. WEST MONROE, LA. 71291-2840
- Store #8935. 3002 CYPRESS STREET. WEST MONROE, LA. 71291
- Store #11335. 5075 CYPRESS STREET. WEST MONROE, LA. 71291
- Store #11721. 5872 JONESBORO ROAD. WEST MONROE, LA. 71292
- Store #1165. 815 W COURT ST. WINNFIELD, LA. 71483-2637
- Store #9066. 3636 FRONT STREET. WINNSBORO, LA. 71295-2224
- Store #9361. 139 MAPLE STREET. WISNER, LA. 71378
- Store #8795. P.O. BOX 1346. YOUNGSVILLE, LA. 70592
- Store #7706. 4950 HWY 19. ZACHARY, LA. 70791
- Store #9411. 601 S MAIN STREET. CHARLESTON, MO. 63834
- Store #2388. 312 W STODDARD ST. DEXTER, MO. 63841-1536
- Store #12555. 125 PRAIRIE DRIVE. EAST PRAIRIE, MO. 63845
- Store #3524. 401 FIRST ST. KENNETT, MO. 63857
- Store #2575. 1031 E MALONE AVE. SIKESTON, MO. 63801
- Store #9188. 209 W MALONE AVENUE. SIKESTON, MO. 63801
- Store #12816. 1409 MAIN STREET. VAN BUREN, MO. 63965
- Store #1194. 1308 PORTER WAGONER BLVD. WEST PLAINS, MO. 65775
- Store #4127. 103 HIGHWAY 45 N. ABERDEEN, MS. 39730-2305
- Store #12611. 222 MABUS STREET. ACKERMAN, MS. 39735
- Store #2324. 209 N 2ND AVE. BALDWYN, MS. 38824-1810
- Store #10384. 4168 HIGHWAY 42. BASSFIELD, MS. 39421
- Store #3246. 116 HIGHWAY 51 N. BATESVILLE, MS. 38606-2347
- Store #2985. 2760D HIGHWAY 15. BAY SPRINGS, MS. 39422
- Store #5124. P.O. BOX 1143. BELMONT, MS. 38827-1143
- Store #1104. 620 E FIRST ST. BELZONI, MS. 39038-3406
- Store #2180. 304 E GOVERNMENT ST. BRANDON, MS. 39042-3262
- Store #10767. 600 E MONTICELLO ST.. BROOKHAVEN, MS. 39601
- Store #3506. 1074 E PEACE ST. CANTON, MS. 39046-4026
- Store #10265. 1131 W PEACE STREET. CANTON, MS. 39046
- Store #11902. 3376 N. LIBERTY STREET. CANTON, MS. 39046-3717
- Store #642. PO BOX 1029. CENTREVILLE, MS. 39631-1029
- Store #3303. 310 W MAIN ST. CHARLESTON, MS. 38921-2231
- Store #849. 620 S STATE ST. CLARKSDALE, MS. 38614-6322
- Store #5493. 1032 N STATE ST. CLARKSDALE, MS. 38614-6524
- Store #3508. 406 S DAVIS AVENUE. CLEVELAND, MS. 38732-3412
- Store #3514. 222 CLINTON BLVD. CLINTON, MS. 39056-5126
- Store #7819. 816 MAIN STREET. COLLINS, MS. 39428
- Store #674. 1412 MAIN ST. COLUMBUS, MS. 39701-4970
- Store #7451. 202 ALABAMA ST. COLUMBUS, MS. 39702
- Store #12672. 60 MIKE PARRA RD. COLUMBUS, MS. 39705-1292
- Store #2941. P. O. BOX 542. CRYSTAL SPRINGS, MS. 39059-0267
- Store #12882. 14916 HIGHWAY 16 W. DE KALB, MS. 39328
- Store #12695. 15458 HIGHWAY 15. DECATUR, MS. 39327
- Store #545. 144 W PARK AVE. DREW, MS. 38737-0443
- Store #1152. 369 E MADISON ST. DURANT, MS. 39063-3713
- Store #8842. 1960 VETERAN'S MEMORIAL BLVD S. EUPORA, MS. 39744
- Store #12656. 101 MANSKER DRIVE. FLORA, MS. 39071
- Store #12548. 1409 S ADAMS STREET. FULTON, MS. 38843
- Store #8769. 437 N CAPTAIN GLOSTER DR. GLOSTER, MS. 39638
- Store #12291. 9563 MAIN ST.. GOODMAN, MS. 39079
- Store #547. 110 N HARVEY ST. GREENVILLE, MS. 38701-3713
- Store #4820. 2101 HIGHWAY 82 E. GREENVILLE, MS. 38703-6029
- Store #8658. 1443 MLK BLVD S.. GREENVILLE, MS. 38703
- Store #12334. 1325 HWY 82 W. GREENVILLE, MS. 38701
- Store #2783. 700 HIGHWAY 7 N. GREENWOOD, MS. 38930
- Store #11610. 320 HIGHWAY 82 W. GREENWOOD, MS. 38930
- Store #5068. 1815 COMMERCE ST. GRENADA, MS. 38901-5106
- Store #10222. 100 N DR. MLK JR. BLVD.. GRENADA, MS. 38901
- Store #8553. 20014 HWY 53. GULFPORT, MS. 39503
- Store #12872. 40055 HAMILTON RD. HAMILTON, MS. 39746
- Store #1119. 215 BROADWAY DR. HATTIESBURG, MS. 39401-5083
- Store #4302. 130 TRADE CENTER LN. HAZELHURST, MS. 39083-2319
- Store #2801. 1002 EAST AVE N. HOLLANDALE, MS. 38748-3222
- Store #632. 183 N. MEMPHIS STREET. HOLLY SPRINGS, MS. 38635-2257
- Store #9228. 3230 GOODMAN ROAD W. HORN LAKE, MS. 38637
- Store #3724. 903C HWY 82 E. INDIANOLA, MS. 38751-2325
- Store #559. 3204 MEDGAR EVERS BOULEVARD. JACKSON, MS. 39213-6842
- Store #1695. 3140 W NORTHSIDE DRIVE. JACKSON, MS. 39213
- Store #3177. 4445 N STATE ST. JACKSON, MS. 39206-5306
- Store #3921. 2566 ROBINSON ST STE B. JACKSON, MS. 39209-7029
- Store #3993. 516 NAKOMA DR. JACKSON, MS. 39206-3332
- Store #5171. 3366 TERRY RD. JACKSON, MS. 39212-4953
- Store #5213. 320 W WOODROW WILSON AVE. JACKSON, MS. 39213-7649
- Store #5535. 2019A RAYMOND RD. JACKSON, MS. 39204-4131
- Store #5870. 3111 W CAPITAL ST. JACKSON, MS. 39209-4204
- Store #6731. 311 BRIARWOOD DR. JACKSON, MS. 39206-3002
- Store #6791. 4747 CLINTON BLVD. JACKSON, MS. 39209-2405
- Store #6938. 3707 S SIWELL RD. JACKSON, MS. 39212-4396
- Store #10443. 2820 TERRY ROAD. JACKSON, MS. 39212
- Store #11570. 1201 UNIVERSITY BOULEVARD. JACKSON, MS. 39204-3055
- Store #11840. 4610 TERRY ROAD. JACKSON, MS. 39212
- Store #12294. 5060 PARKWAY DRIVE. JACKSON, MS. 39211
- Store #2800. 329 HIGHWAY 12 EAST. KOSCIUSKO, MS. 39090-3420
- Store #546. 604 N BROAD ST. LELAND, MS. 38756-2622
- Store #658. 327 DEPOT ST. LEXINGTON, MS. 39095-3606
- Store #8084. 332 E MAIN ST. LIBERTY, MS. 39645
- Store #10530. 401 SOUTH CHURCH AVENUE. LOUISVILLE, MS. 39339-2921
- Store #4103. 601 S JEFFERSON ST. MACON, MS. 39341-3009
- Store #8040. 115 N. CLARK AVE.. MAGNOLIA, MS. 39652-2821
- Store #12554. 67 WATSON DRIVE. MANTACHIE, MS. 38855
- Store #10507. 5321 DALE DRIVE. MARION, MS. 39342
- Store #4108. 713 MARTIN LUTHER KING DR.. MARKS, MS. 38646
- Store #778. 1209 DELAWARE AVE. MC COMB, MS. 39648-3763
- Store #5460. 1200 LASALLE ST. MCCOMB, MS. 39648
- Store #8358. P.O. BOX 709. MEADVILLE, MS. 39653-0709
- Store #10905. 1736 SIMPSON HIGHWAY 149. MENDENHALL, MS. 39114-3423
- Store #2182. 2815 8TH STREET. MERIDIAN, MS. 39301-4845
- Store #7601. 713 E BROAD ST. MONTICELLO, MS. 39654-7707
- Store #6603. 395 JOHN R JUNKIN DR. NATCHEZ, MS. 39120-3823
- Store #11577. 1196 N MARTIN LUTHER KING JR S. NATCHEZ, MS. 39120-3162
- Store #12723. 188 NORTHSIDE DRIVE. NEWTON, MS. 39345
- Store #12707. 511 W MONROE AVENUE. OKOLONA, MS. 38860
- Store #2727. 3123 HWY 80 E. PEARL, MS. 39208-3503
- Store #10158. 621 SOUTH PEARSON ROAD. PEARL, MS. 39208
- Store #10844. 800 E MAIN STREET. PHILADELPHIA, MS. 39350
- Store #2450. P O BOX 41. PORT GIBSON, MS. 39150-0041
- Store #3354. PO BOX 1556. PRENTISS, MS. 39474
- Store #566. 548 S ARCHUSA AVE. QUITMAN, MS. 39355-2416
- Store #12170. 202 WHITE OAK. RALEIGH, MS. 39153
- Store #12887. 825 E MAIN STREET. RAYMOND, MS. 39154
- Store #10157. 1606 E COUNTY LINE ROAD. RIDGELAND, MS. 39157-1906
- Store #12328. 398 HWY 51. RIDGELAND, MS. 39157
- Store #7922. 1115 CASINO CENTER DR.. ROBINSONVILLE, MS. 38664
- Store #12474. 20503 HIGHWAY 61. ROLLING FORK, MS. 39159
- Store #4319. P O BOX 218. RULEVILLE, MS. 38771-0218
- Store #12579. 23 HWY 590 W. SEMINARY, MS. 39479
- Store #12943. 13824 US-98. SMITHDALE, MS. 39664
- Store #3443. 8650 HIGHWAY 51 N. SOUTHAVEN, MS. 38671-2924
- Store #10236. 980 CHURCH RD. W.. SOUTHAVEN, MS. 38671-9611
- Store #565. 213 N JACKSON STREET. STARKVILLE, MS. 39759-2501
- Store #10203. 1440 US HWY. 61 N. TUNICA, MS. 38676
- Store #523. 701 W MAIN ST. TUPELO, MS. 38804-3707
- Store #6109. 900 BEULAH AVE. TYLERTOWN, MS. 39667-2174
- Store #10393. 803 E JACKSON ROAD. UNION, MS. 39365
- Store #12766. 34195 HIGHWAY 35. VAIDEN, MS. 39176
- Store #2483. 2080 S FRONTAGE ROAD. VICKSBURG, MS. 39180
- Store #6160. 1305 MISSION 66. VICKSBURG, MS. 39180-3365
- Store #11162. 135 HIGHWAY 27. VICKSBURG, MS. 39180
- Store #12444. 1800 HIGHWAY 61, NORTH. VICKSBURG, MS. 39183
- Store #12445. 5100 HWY 61 SOUTH. VICKSBURG, MS. 39180
- Store #12720. 409 DUNCAN STREET. WATER VALLEY, MS. 38965
- Store #11941. 2071 HIGHWAY 51. WESSON, MS. 39191
- Store #12666. 106 S APPLEGATE STREET. WINONA, MS. 38967
- Store #8499. 184 MAIN ST.. WOODVILLE, MS. 39669
- Store #2799. 301 BROADWAY STREET. YAZOO, MS. 39194
- Store #5957. 760 E 15TH ST. YAZOO CITY, MS. 39194-2706
- Store #10798. 306 E. MAIN STREET. ADAMSVILLE, TN. 38310-2318
- Store #4418. 2686 KIRBY WHITTEN RD. BARTLETT, TN. 38133
- Store #8323. 1745 SYCAMORE VIEW RD.. BARTLETT, TN. 38134-6517
- Store #2850. 605 W MARKET STREET. BOLIVAR, TN. 38008-2240
- Store #10605. 605 E MAIN STREET. BROWNSVILLE, TN. 38012-2627
- Store #10252. 1683 APPLING RD.. CORDOVA, TN. 38016-4907
- Store #10467. 9109 US 64. CORDOVA, TN. 38016
- Store #2748. 605 HWY 51 N. COVINGTON, TN. 38019
- Store #3283. 1935 ST JOHN AVE #C. DYERSBURG, TN. 38024-2132
- Store #12020. 228 HIGHWAY 57 W. GRAND JUNCTION, TN. 38039-4268
- Store #4235. 121 WHITLEY AVE. HENDERSON, TN. 38340-2221
- Store #1113. 903 HOLLYWOOD DR. JACKSON, TN. 38301-4764
- Store #3995. 1011 OLD HICKORY BLVD. JACKSON, TN. 38305-2483
- Store #6127. 224 N ROYAL ST. JACKSON, TN. 38301-6341
- Store #9380. 1000 WHITEHALL STREET. JACKSON, TN. 38301
- Store #10627. 1301 N HIGHLAND AVENUE. JACKSON, TN. 38301-4018
- Store #624. 117 W. CHURCH STREET. LEXINGTON, TN. 38351
- Store #12886. 211 THREE OAKS DRIVE. MEDINA, TN. 38355-1501
- Store #699. 3223 WINCHESTER RD. MEMPHIS, TN. 38118-4827
- Store #723. 2168 FRAYSER BLVD. MEMPHIS, TN. 38127-5755
- Store #724. 3975 JACKSON AVE. MEMPHIS, TN. 38128-6670
- Store #751. 3190 N THOMAS #3192. MEMPHIS, TN. 38127-6001
- Store #759. 4100 S PLAZA DR. MEMPHIS, TN. 38116-6335
- Store #820. 142 N AVALON ST. MEMPHIS, TN. 38104-2408
- Store #876. 2920 LAMAR AVE. MEMPHIS, TN. 38114
- Store #1170. 4724 MILLBRANCH RD. MEMPHIS, TN. 38116-8031
- Store #1555. 3400 SUMMER AVENUE. MEMPHIS, TN. 38122
- Store #1568. 1107 S BELLEVUE BLVD. MEMPHIS, TN. 38106-2344
- Store #2723. 2500 ELVIS PRESSLEY BLVD. MEMPHIS, TN. 38106-8333
- Store #3370. 3682 NORTH WATKINS ST. MEMPHIS, TN. 38127-4361
- Store #3398. 4689 KNIGHT ARNOLD RD. MEMPHIS, TN. 38118-3234
- Store #3412. 3242 JACKSON AVE. MEMPHIS, TN. 38122-1009
- Store #3537. 4216 SUMMER AVE. MEMPHIS, TN. 38122-4044
- Store #4181. 2570 FRAYSER BLVD. MEMPHIS, TN. 38127-5829
- Store #5362. 2912 COLEMAN RD. MEMPHIS, TN. 38128
- Store #5671. 4330 WINCHESTER RD. MEMPHIS, TN. 38118
- Store #5803. 3315 E SHELBY DR. MEMPHIS, TN. 38118-7256
- Store #5844. 4727 NEELY RD. MEMPHIS, TN. 38109-8550
- Store #5898. 3566 S MENDENHALL RD. MEMPHIS, TN. 38115-4512
- Store #5960. 6636 E SHELBY DR. MEMPHIS, TN. 38141-8439
- Store #5984. 5355 ELVIS PRESLEY BLVD. MEMPHIS, TN. 38116-8235
- Store #6010. 3141 S MENDENHALL RD. MEMPHIS, TN. 38115-2827
- Store #6097. 3255 HICKORY HILL RD. MEMPHIS, TN. 38115-3135
- Store #6105. 3338 AUSTIN PEAY HWY. MEMPHIS, TN. 38128-3802
- Store #6439. 2743 N WATKINS ST. MEMPHIS, TN. 38127-8564
- Store #6465. 2981 PARK AVE. MEMPHIS, TN. 38114-2731
- Store #6487. 3515 RIDGEMONT AVE. MEMPHIS, TN. 38128-1830
- Store #6708. 3435 MILLBRANCH RD. MEMPHIS, TN. 38116-3625
- Store #6818. 3500 RAMILL ROAD. MEMPHIS, TN. 38128
- Store #6892. 6415 E RAINES RD. MEMPHIS, TN. 38115-6540
- Store #7230. 2374 SUMMER AVE. MEMPHIS, TN. 38112-2518
- Store #8027. 287 N. CLEVELAND ST.. MEMPHIS, TN. 38104-7145
- Store #8417. 2715 S PERKINS ROAD. MEMPHIS, TN. 38118-2430
- Store #8516. 1636 GETWELL RD. MEMPHIS, TN. 38111-7120
- Store #8558. 180 EAST E H CRUMP BLVD. MEMPHIS, TN. 38106-1714
- Store #8579. 831 THOMAS ST. MEMPHIS, TN. 38107-2543
- Store #8580. 3390 S US HIGHWAY 61. MEMPHIS, TN. 38109
- Store #8597. 2760 LAMAR AVE.. MEMPHIS, TN. 38114-4316
- Store #8610. 656 S HIGHLAND STREET. MEMPHIS, TN. 38111-4356
- Store #8681. 1870 N GERMANTOWN PKWY.. MEMPHIS, TN. 38016-2815
- Store #8690. 1427 N HOLLYWOOD ST.. MEMPHIS, TN. 38108-1533
- Store #8691. 6550 MT. MORIAH RD. MEMPHIS, TN. 38115
- Store #8694. 2644 JAMES RD. MEMPHIS, TN. 38127-8811
- Store #8735. 4082 US HIGHWAY 61 SUITE 101. MEMPHIS, TN. 38109
- Store #8814. 4280 MACON RD. MEMPHIS, TN. 38122-4811
- Store #8865. 3544 COVINGTON PIKE. MEMPHIS, TN. 38128-3926
- Store #8866. 1539 WHITTEN ROAD. MEMPHIS, TN. 38134
- Store #8953. 4202 HACKS CROSS RD. MEMPHIS, TN. 38125
- Store #8979. 2711 GETWELL RD. MEMPHIS, TN. 38118
- Store #8980. 2970 POPLAR AVENUE. MEMPHIS, TN. 38111
- Store #8992. 4618 QUINCE RD. MEMPHIS, TN. 38117-6547
- Store #9011. 2360 AIRWAYS BLVD.. MEMPHIS, TN. 38114-6009
- Store #9049. 1688 JACKSON AVENUE. MEMPHIS, TN. 38107
- Store #9229. 3403 ELVIS PRESLEY BLVD. MEMPHIS, TN. 38116-3259
- Store #9341. 5245 RIVERDALE ROAD. MEMPHIS, TN. 38141-8551
- Store #11549. 4194 HICKORY HILL ROAD. MEMPHIS, TN. 38141-6814
- Store #11664. 910 JACKSON AVENUE. MEMPHIS, TN. 38107-4134
- Store #11811. 6222 WINCHESTER ROAD. MEMPHIS, TN. 38115-4175
- Store #11953. 1450 S TREZEVANT STREET. MEMPHIS, TN. 38114-6607
- Store #12821. 716 S MAIN ST. MIDDLETON, TN. 38052
- Store #854. 4839 NAVY RD. MILLINGTON, TN. 38053-2030
- Store #6044. 1345 MUNFORD AVENUE. MUNFORD, TN. 38058-6749
- Store #12531. 503 TENNESSEE AVENUE N. PARSONS, TN. 38363
- Store #4175. 101 LAKE ST. RIDGELY, TN. 38080-1314
- Store #582. 180 SOUTH WASHINGTON STREET. RIPLEY, TN. 38063-1514
- Store #779. 2007 WAYNE RD. SAVANNAH, TN. 38372-2235
- Store #4539. 17575 US HWY 64. SOMERVILLE, TN. 38068
- Store #633. 128 DAVY CROCKETT MALL. TRENTON, TN. 38382-2934
Baxter International Inc. announced today it has issued an Urgent Safety Communication to reinforce important safety information regarding upstream occlusion alarms for all Spectrum V8 and Spectrum IQ infusion pumps. Incorrect administration set setup and/or incomplete resolution of upstream occlusion alarms may result in reduced delivery or... non-delivery of medication, in some cases without alerting the user via pump alarm. Spectrum V8 and Spectrum IQ are distributed in the United States, Puerto Rico, Canada and certain Caribbean islands.
Baxter previously communicated this information to customers via an Urgent Safety Communication notification on December 29, 2021. Customers notified Baxter that the pump was not delivering medication at the programmed rate displayed on the screen, and in some cases was not alarming for upstream occlusions.
As described in the Urgent Safety Communication notification, after an upstream occlusion alarm, it is imperative to fully resolve any upstream occlusion before restarting the pump. Failure to do so may cause the pump not to re-alarm as expected, which can lead to interruption in therapy and/or under-infusion. The potential harm to the patient depends on several factors such as length of therapy delay, medication being infused, volume and rate of infusion, and the patient’s underlying status and comorbidities.
To date, Baxter has received 51 reports of serious injury and three reports of patient death over five years that may have resulted from incorrect administration set setup and/or incomplete resolution of upstream occlusion alarms. Customers may continue to use Spectrum V8 and Spectrum IQ infusion pumps by following on-screen instructions and referencing the Operator’s Manual for infusion setup instructions in the Preparing the Pump and IV Sets and Programming the Pump sections and upstream occlusion alarm troubleshooting in the Alarms section.
To help prevent upstream occlusions, it is important to completely spike the IV container, remove the blue slide clamp completely from the keyhole, disengage the blue slide clamp completely from the IV tubing, check that the IV tubing is clear of any kinks or collapsed sections, ensure the roller clamp (if present) is released prior to infusion start, and ensure that rigid and semirigid containers are properly vented. After starting an infusion, it is important to verify that drips are flowing in the drip chamber, which may take several minutes when infusing at flow rates below 5 mL/hr. If an upstream occlusion remains after the RUN/STOP key is pressed, the pump may appear to be infusing normally but may be infusing below the programmed rate or not infusing at all. If a clinician suspects that they resumed an infusion without clearing an occlusion, they should stop the infusion by pressing the RUN/STOP key, clear the occlusion and restart the infusion.
Product Code: 35700BAX2
Product Description: SIGMA Spectrum Infusion System (V8 Platform)
Unique Device Identifier: GTIN 00085412498683
Serial Number: All
Manufacturing Date: July 1, 2014 – June 8, 2021
Release Date: Feb. 5, 2015 - Present
Released Quantity (Units): 140,674
Product Code: 3570009
Product Description: Spectrum IQ Infusion System with Dose IQ
Unique Device Identifier: Safety Software 00085412610900
Serial Number: All
Manufacturing Date: June 29, 2017 - Present
Release Date: Dec. 6, 2017 - Present
Released Quantity (Units): 175,028
Check the full recall details on fda.gov
SD Biosensor, Inc., a global in-vitro diagnostics company, is voluntarily recalling its STANDARD Q COVID-19 Ag Home Test in the United States, due to confirmed reports that the test kits were illegally imported into the United States. The STANDARD Q COVID-19 Ag Home Test is not authorized,... cleared or approved by the U.S. Food and Drug Administration (FDA) for distribution or use in the United States. While there is no known distribution of these tests directly to consumers, SD Biosensor, Inc. is issuing this voluntary recall out of an abundance of caution.
STANDARD Q COVID-19 Ag Home Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigen present in human nasal sample. It provides only an initial screening test result. The result of this test should not be the sole basis for the diagnosis; conﬁrmatory testing is required.
In the unlikely event that consumers in the United States encounter the ‘STANDARD Q COVID-19 Ag Home Test’, they are encouraged to discard and avoid any use of the test, as it has not been authorized, cleared or approved by the FDA for use in COVID-19 testing and diagnosis in the United States. Consumers that have used the test are strongly encouraged to consider retesting with an FDA authorized or cleared test.
SD Biosensor, Inc. considers illegal importation to be a grave matter. In addition to issuing a voluntary recall for the ‘STANDARD Q COVID-19 Ag Home Test’, SD Biosensor, Inc. has initiated an investigation to determine how the product was illegally imported into the United States. Distributors or individuals who illegally imported the products initially sold outside the United States will be ordered to stop the illegal activity and initiate an immediate product recall.
SD Biosensor, Inc. is taking appropriate measures to prevent further attempts at illegal importation of unauthorized tests by strengthening contract terms and their enforcement with its distributors. In addition, the company announced publicly that if such illegal importations are discovered in the future, the responsible individuals/distributors will face strict legal action and liabilities for damages.
Company name: SD Biosensor, Inc.
Brand name: SD Biosensor, Inc.
Product recalled: STANDARD Q COVID-19 Ag Home Test
Reason of the recall: illegally imported into the United States
FDA Recall date: February 04, 2022
Check the full recall details on fda.gov
Imtmedical ag, a subsidiary of Vyaire Medical, initiated a voluntary field correction for certain bellavista™ ventilators. With specific software version and configuration combinations, the ventilators can cease ventilation and generate a technical failure alarm 305. There is a potential issue with bellavista™ 1000 and 1000e ventilators that... have software version 6.0.1600.0 or higher installed, which was deployed in February 2021, and also have the Data Communication port set to “HL7”.
Customers with software version 6.0.1600.0 or higher installed have been notified by Vyaire to immediately disable the HL7 data communication if activated. If the HL7 data communication is not disabled, such devices are at risk of the reported unintentional ceasing of ventilation. This decision is based on the receipt of reports that some bellavista™ 1000 and 1000e ventilators have unintentionally ceased ventilation during clinical use and require rebooting to resume ventilation due to a software issue. An internal investigation determined that bellavista 1000 and 1000e ventilators with software version 6.0.1600.0 or higher installed can have a conflict in memory resource allocation between software tasks when the Data Communication port is set to “HL7”.
The ventilator notifies the user of the issue by triggering technical failure alarm 305 indicating an interruption in the communication between the user interface controller (EPC) and the ventilation controller (CFB). No patient harm has been reported related to this issue.
If clinicians operate a bellavista™ ventilator and do not set Data Communication port to “HL7”, this error will not occur. Therefore, Vyaire supports the continued use of these devices and directs customers to follow the instructions provided in the Company’s correction notification to immediately disable the HL7 data communication if activated while the company develops and deploys a software update to address the issue, anticipated in Q1 of calendar year 2022.
The affected ventilators were distributed to medical facilities in the US between 3/21/19 through 12/23/21 located in the following states: AL, CA, CO, CT, DC, FL, GA, ID, IL, IN, LA, MA, MD, MI, MO, MS, NC, NJ, NY, OH, OK, PA, PR SD, TX, VA, WA, WI and WV.
Company name: Vyaire Medical
Brand name: bellavista™
Product recalled: ventilators
Reason of the recall: Ventilators can cease ventilation and generate a technical failure alarm 305
FDA Recall date: February 04, 2022
Check the full recall details on fda.gov
Oscor Inc. is voluntarily recalling 14 lots of Destino Twist 14F model DST1405525 & Guidestar 14F model D141103 down to the user level. The Destino Twist 14F model DST1405525 & Guidestar 14F model D141103 have been found to have increased risk of the hub cap and seal... on the proximal end of the device handle detaching during use.
RISK STATEMENT: The Destino Twist 14T Model DST1405525 & Guidestar 14F Model D141103 detachment of the hub cap and seal could lead to bleeding at the proximal end of the device and/or air embolism for the patient during intracardiac, renal or other peripheral placements procedures.
Oscor Inc. has reported two (2) Medical Device Reports to the FDA related to detachment of hub cap and seal on the proximal end of the device handle. The recall is limited to the two model numbers and lot numbers outlined above. There are no other recalls associated with this product.
PRODUCT INFORMATION: The product is steerable guiding sheath intended for the introduction of diagnostic and therapeutic devices into the human vascular, including but not limited to intracardiac, renal or other peripheral placements; it cannot be use for neural placements. The product is provided sterile, one unit per pouch / tray for details and can be identified on the printed labeling with the information below (1, 2, and 3).
The affected Destino Twist 14F model DST1405525 & Guidestar 14F model D141103 were distributed Worldwide to distributors and hospitals from June 8, 2021 to November 30, 2021.
Recalled Product Impacted (1)
- Destino Twist 14F (DST1405525). UDI Number: 885672011123. Lot Number: PQOC13475. Expiration Date 10-01-2021. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: DP14073. Expiration Date 11-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: DP14072. Expiration Date 10-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: DP14071. Expiration Date 10-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: DP13834. Expiration Date 09-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: DP13828. Expiration Date 09-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: DP13827. Expiration Date 08-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: PQOC12995. Expiration Date 07-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: PQOC12632. Expiration Date 07-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: PQOC12633. Expiration Date 07-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: PQOC12345. Expiration Date 06-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: PQOC12330. Expiration Date 06-01-2025. Packaging State Type: Sterile.
Destino 14F Twist Model (2)
Product: Destino Twist 14F
GTIN (Unit): 00885672011123
Sheath & Dilator: S55CM D73CM
French Size: 14F
Quantity: 6 Units
Guidestar 14F - Model (3)
Product: Guidestar 14F
GTIN (Unit): 00885672010911
Sheath & Dilator: S71CM D89CM
French Size: 14F
Quantity: 543 Units
Company name: Oscor Inc.
Brand name: Oscor
Recalled: Destino Twist 14F model DST1405525 & Guidestar 14F model D141103 steerable guiding sheath
Reason of the recall: Hub cap and seal on the proximal end of the device handle may detach during use
FDA Recall date: January 12, 2022
Check the full recall details on fda.gov
6 months ago
On August 19, 2021, Aligned Medical Solutions initiated a nationwide recall of Cardinal Health’s Monoject™ Flush Prefilled Saline Syringes placed into 9,378 kits. Including:
- 1 lot of AMS-9041CP Leaderflex Insertion Kit with Ultrasound
- 1 lot of AMS-9046CP-1 Insertion Tray-RX
- 45 lots of AMS8939A Universal... Procedure Pack w/Split Drape
- 1 lot of AMS9957A Port Insertion Pack
- 3 lots of AMS12149 Procedure Pack
These convenience kits have been found to contain the Cardinal Health’s Monoject™ Flush Prefilled Saline Syringe part # 8881570121, which has been recalled for the potential for the plunger to draw back after the air has been expelled and reintroduced air back into the syringe. If a clinician is not aware of air being introduced into the syringe, the clinician could inadvertently push air into the vascular system creating the potential for an air embolism. Injection of air into the vascular system can cause air embolism which can result in serious adverse health consequences or death.
Consumers who have affected product(s) should immediately review their inventory and quarantine all affected kits. Customers will be provided with a yellow label that is to be placed on the packs containing the recalled Cardinal Health’s Monoject™ Flush Prefilled Saline Syringe. The label will read as follows; At the time the kit is opened for use the prefilled syringe manufactured by Cardinal Health should be identified, set aside and not used. Do not use the prefilled syringe in the kit.
The recalled prefilled syringe should be rendered unusable to protect against inadvertent use and disposed or pursuant to the medical waste policies in effect at your institution
Recalled Product(s) were manufactured from 01/13/2020 to 10/14/2020 and distributed from 01/23/2020 to 10/19/2020. The following kit part numbers and lot numbers containing the recalled /affected Cardinal Health Monoject™ Flush Prefilled Syringes have been recalled:
- Formula No. AMS-9041CP. Description: 136833. Item No.: Leaderflex Insertion Kit with Ultrasound.
- Formula No. AMS-9046CP-1. Description: 137794. Item No.: Insertion Tray-RX.
- Formula No. AMS8939A . Description: 140390, 141087, 141088, 141096, 141097, 141098, 141100, 141101, 141102, 141717, 145615, 146037,146039, 146349, 146351, 146766, 146768, 146905, 146908, 147902, 147903, 148409, 148410, 148411, 148412, 148413, 148414, 148450, 148451, 148452, 148636, 148638, 148639, 148640, 149131, 149132, 149133, 149134, 149135, 149136, 149137, 149138, 149484, 149485, 149486. Item No.: Universal Procedure Pack w/Split Drape.
- Formula No. AMS9957A. Description: 147773. Item No.: Port Insertion Pack.
- Formula No. AMS12149. Description: 145718, 146897, 148612. Item No.: Procedure Pack.
Product(s) can be identified by the pack label inside the sterile barrier of the convenience kit.
Aligned Medical Solutions has notified the FDA of this action.
No injuries have been reported to date.
Aligned Medical Solutions is notifying its distributors by email and will arrange for labels to identify the packs with the recalled syringe. Aligned Medical Solutions will also arrange for replacement syringes to be sent for all recalled product(s).
Aligned Medical Solutions distributed these packs Nationwide.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Company name: Windstone Medical Packaging dba Aligned Medical Solutions
Brand name: Cardinal Health’s Monoject™
Product recalled: Flush Prefilled Saline Syringes
Reason of the recall: Potential for the plunger to draw back after the air has been expelled and reintroduced air back into the syringe
FDA Recall date: October 27, 2021
Check the full recall details on fda.gov
Cook Medical Transseptal Needle and Transseptal Needle Catheter - recalled due to Complaints of rust on the products, USA
7 months ago
Company name: Cook Medical
Brand name: Cook Medical
Product recalled: Transseptal Needle and Transseptal Needle Catheter
Reason of the recall: Complaints of rust on the products
FDA Recall date: October 19, 2021
Recall details: Bloomington, Ind. — On October 8, 2021, Cook Medical issued a global, voluntary... recall of the Transseptal Needle and the Transseptal Needle with Catheter. This recall includes all unexpired lots for both of these products. The needles were recalled due to complaints of rust on the products. Use of affected products could result in increased procedural time and inflammatory reactions, including systemic reactions which may lead to permanent impairment or death.
The U.S. Food and Drug Administration (FDA) has not yet classified the recall. Products affected by this recall are:
- Transseptal Needle, INTENDED USE: Intended for transseptal left heart access in both diagnostic and interventional procedures, RPN: TSNC-18-71.0 GPN: G02364 and RPN: TSNC-19-56.0 GPN: G02365, all lot numbers, RANGE OF MANUFACTURE DATES FOR AFFECTED PRODUCTS: October 02, 2016 through July 22, 2021
- Transseptal Needle with Catheter, INTENDED USE: Intended to facilitate transseptal entry into the left atrium, RPN: TSN-17-75.0-ENDRYS, GPN: G19261, all lot numbers, RANGE OF MANUFACTURE DATES FOR AFFECTED PRODUCTS: October 02, 2016 through July 22, 2021
Transseptal Needles, including Transseptal Needles with Catheters, were found to have rust internally, externally, or both. To date, Cook Medical has received no reports of injury or illness related to this recall. Cook has received four complaints where the presence of rust was identified prior to patient contact. However, please be advised that the presence of rust may go undetected by the user. The FDA and other regulatory agencies around the world have been notified of this action.
Potential adverse events: If an affected product is used, potential negative outcomes include increased procedural time (to obtain a replacement device) and inflammatory reactions ranging from local or self-limited reactions to systemic reactions requiring medical intervention. Systemic reactions could potentially lead to permanent impairment or death.
Check the full recall details on fda.gov
Company name: Meridian Bioscience, Inc.
Brand name: Meridian Bioscience, Inc.
Product recalled: LeadCare® Test Kits
Reason of the recall: LeadCare Test Kits lots could potentially underestimate blood lead levels when processing patient blood samples
FDA Recall date: September 02, 2021
Recall details: Meridian Bioscience, Inc. (NASDAQ: VIVO),... a provider of diagnostic testing solutions and life science raw materials, today announced its wholly owned subsidiary, Magellan Diagnostics, Inc. (“Magellan”), expanded the Class I recall of its LeadCare® II Blood Lead Test Kits, LeadCare Plus® Blood Lead Test Kits, and LeadCare Ultra® Blood Lead Test Kits (the “LeadCare Test Kits”) for the detection of lead in whole blood.
Magellan provides two controls in the test kits which are designed to mimic blood and are spiked with lead to specific target values with an associated acceptable range. Results of the control tests within the acceptable range indicate that the system is operating properly before testing patient samples.
In May 2021, Magellan initiated this voluntary recall after identifying an ongoing issue with testing of the controls included in the LeadCare Test Kits. Magellan continues to investigate this issue and has conducted extensive testing to evaluate potential root causes.
Scope of Recall: Magellan received reports that control tests of either the “Low-Control” (e.g., the “Level 1” control at approximately 9 g/dL ± 3g/dL) and/or the “High-Control” (e.g., the “Level 2” control at approximately 28 g/dL ± 4g/dL) generated a “low” result (i.e., “Control Out of Range-Low” [“COOR-L”]).
Magellan initiated the recall because the impacted LeadCare Test Kits lots could potentially underestimate blood lead levels when processing patient blood samples. As part of the recall to the user level, Magellan is notifying customers and distributors affected by the recall. Magellan's customer recall notification provides instructions for the return and replacement of the impacted LeadCare Test Kits (see list of affected lot numbers in the link below).
Magellan recommends the following:
- Customers should discontinue use of all LeadCare Test Kits lots identified as part of the recall and quarantine remaining inventory.
- Distributors should stop distribution of all LeadCare Test Kits lots identified as part of the recall, review current inventory and quarantine any remaining stock.
- Health Care Providers should evaluate patient test results that were generated with all recalled lots.
- Suspect results should be confirmed with an alternative lead testing option, such as those using Inductively Coupled Plasma Mass Spectrometry (ICP-MS) or Graphite Furnace Atomic Absorption Spectroscopy (GFAAS) at a high complexity, CLIA-certified, reference laboratory.
- See CDC’s recommended actions based on blood lead level
- Promptly complete and return the Customer Notification Form in the Urgent Medical Device Recall letter to FAX to (978) 600-1480. Complete this form even if you have no remaining inventory.
- After the form has been submitted, contact Magellan Technical Support 1-800-275-0102 to obtain a FedEx label to return any remaining inventory to Magellan and receive replacement product when available.
Product distribution has been paused until further notice and replacement product is currently unavailable. Magellan continues to investigate the root cause of the COOR-LO failure mode and is working diligently to find a solution to resume shipments/replacements as quickly as possible. If you have questions about this recall, please contact Magellan’s LeadCare® Product Support Team at 1-800-275-0102
Check the full recall details on fda.gov
Company name: Baxter International Inc.
Brand name: Spectrum IQ
Product recalled: Infusion Pumps
Reason of the recall: Multiple Connectivity Errors
FDA Recall date: August 24, 2021
Recall details: Baxter International Inc. announced today it has issued an Urgent Medical Device Correction for all Spectrum IQ infusion pumps... to reinforce important safety information when customers implement changes to their network configuration and server systems. Baxter previously communicated this information to customers via an Urgent Medical Device Correction notification on June 4, 2021 and a follow-up communication with updated information on August 2, 2021.
Two Spectrum IQ infusion pump customers notified Baxter of system errors occurring in multiple pumps within their fleets following changes the customers implemented to the configuration of their network and server systems. Gateway Server System performance anomalies resulted in multiple pump connectivity errors, placing stress on the pump’s processor. When this occurs, pumps initiate a “watchdog” system error alarm to notify the user of the issue, causing the pump to enter a fail-safe mode which stops all pump processes, including delivery of fluid to the patient. For both customers, the watchdog system errors were resolved by restoring network and server system performance to expected levels.
- Spectrum IQ Infusion System with Dose IQ Safety Software. Product Code: 3570009. Serial Numbers: All
To date, there have been no reports of adverse events or patient injury associated with this issue. However, depending on several factors, such as the length of delay, medication being infused, the volume and rate of the infusion, patient status, and comorbidities, the patient may experience serious adverse health consequences or death. Baxter is developing a software upgrade for all Spectrum IQ infusion pumps that will assist how the pump responds to unstable network and server systems by reducing the stress on the pump’s memory and processing functions if this occurs.
The updated software is currently expected to be available early in the fourth quarter of 2021, and Baxter will work with customers to schedule the software upgrades. To reduce the likelihood of encountering this issue, Baxter is asking customers to contact Baxter Technical Assistance at 800-356-3454 in advance of making changes to their network or server infrastructure supporting the pumps or the Baxter Gateway. Changes requiring prior notice can be found in the Urgent Medical Device Correction communication and in Baxter’s Gateway Server Installation Handoff document, which customers receive upon installation. Additionally, Baxter recommends that customers ensure backup devices are readily available when infusing critical medications.
Customers with additional questions can contact their Baxter sales representative or Baxter Technical Assistance at 800-356-3454 (choose option 1) Monday through Friday between 6 a.m. and 6 p.m. Central Time. Baxter is voluntarily issuing this Urgent Medical Device Correction with the knowledge of the U.S. Food and Drug Administration.
Check the full recall details on fda.gov
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