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Medical Devices

Updated: January 5, 2023 12:00 PM
Smiths Medical issued an Urgent Medical Device Correction Letter to notify affected customers of two potential issues with CADDTM Infusion System Infusion Sets related to potential lack of delivery or underdelivery and false no disposable attached (NOA) alarms. The letter details the issues, the affected items, the... See More required steps to perform, and specific instructions for treatment of patients requiring life sustaining therapy.

The first issue, lack of delivery or underdelivery, may occur due to manufacturing variations that can potentially cause the green CADD Flow Stop arm to compress partially occlude the tubing before clinical use. If this happens, there is a potential that the occlusion does not resolve when the CADD reservoir or administration set is connected to the pump, and the pump may not detect the occlusion. This may result in underdelivery or non-delivery of medication, despite the pump displaying that the infusion is running properly.

The second issue, false "no disposable attached" (NOA) alarms, is specific to CADD-Legacy pumps, which Smiths Medical announced the discontinuation of sale effective December 37, 2022. There is a potential that CADD-Legacy pumps may not detect that 50 ml and 700 ml CADD Medication Cassette Reservoirs with Flow Stop are attached to the pump when they are properly attached. When this happens, the pump will initiate an NOA alarm if the NOA double-beep warning is not resolved within 2 minutes. The user must clear the alarm and resolve the cause of the NOA event before using the pump. This issue does not impact 250 ml Flow-Stop and non-Flow Stop CADD Medication Cassette Reservoirs.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance.

Company name: Smith’s Medical
Brand name: Smith’s Medical
Product recalled: CADD Infusion System Infusion Sets for use with CADD pumps
Reason of the recall: Potential lack of delivery or underdelivery and false no disposable attached (NDA) alarms.
FDA Recall date: January 05, 2023

Source: fda.gov
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Xiamen, Fujian, GFA Production (Xiamen) Co., Ltd. is voluntarily recalling one lot of Easy Care first aid® AfterBurn ® Cream, 0.9 g single-use packets. The single use packets are sold in boxes of 10 or packaged in certain First Aid kits. This recall is to the consumer... See More level. FDA analysis found the product to be contaminated with Bacillus licheniformis, and Bacillus sonorensis. The product was distributed nationwide to retailers from March 4, 2022 through December 12, 2022. To date, GFA Production (Xiamen) Co., Ltd. has not received any reports of adverse events related to this recall.

Risk Statement: In immunocompromised patients, the topical use of the contaminated Easy Care® AfterBurn® Cream 0.9g single-use packets could potentially result in severe or life-threatening adverse events such as bacteremia, sepsis, and peritonitis. In non-immunocompromised patients, the population most likely to use the product, the use of the defective product may result in infectious complications, for instance skin infections, but in this population the infections are expected to be less severe and more readily responsive to treatment.

The Easy Care first aid® AfterBurn® Cream 0.9 g single-use packet, is used as an over the counter first-aid treatment for minor burns. The single use packets bear lot number W06I28 and are  packaged in boxes of ten or included in the certain First Aid kits named below.  

The lot number of the single use packet can be found on the back of the packet.  The lot number for the First Aid Kit that contains the single use packet can be found on each kit, either on the product hang-tag or on the bottom of the kit.

Refer to the images below for guidance on where to find the lot code details.  If your product does not have a lot code that is listed in the below table then it is not part of this recall and can be used as intended.

Package: Box of 10
Product Number: 9999-1515
Product Description: EasyCare First Aid® AfterBurn® Cream, 0.9g single-use packet
Lot number: W06I28
Expiration: 09/28/2024

Package: First Aid Kit
Product Number: 1015-0150
Product Description: Adventure® Marine 150
Lot number: W06I20
Expiration: 09/20/2024

Package: First Aid Kit
Product Number: 0120-0213
Product Description: Adventure® First Aid 1.0
Lot number: W06C05 W06F10 W06H15
Expiration: 03/05/2024 06/10/2024 08/15/2024

Package: First Aid Kit
Product Number: 0120-0212
Product Description: Adventure® First Aid 1.5
Lot number: W06H15
Expiration: 08/15/2024

Package: First Aid Kit
Product Number: 9999-2129
Product Description: Easy Care First Aid® 25 Person 2009 ANSI
Lot number: W05L28
Expiration: 12/28/2023

Package: First Aid Kit
Product Number: 9999-2128
Product Description: Easy Care First Aid® 10 Person 2009 ANSI
Lot number: W05L28 W06F10 W06H15
Expiration: 12/28/2023 06/10/2024 08/15/2021

Package: First Aid Kit
Product Number: 9999-2150
Product Description: Easy Care First Aid® Class A ANSI 25 Person
Lot number: W06C05 W06H15
Expiration: 03/05/2024 08/15/2024

Package: First Aid Kit
Product Number: 9999-2132
Product Description: Easy Care First Aid® 25 Person 2009 ANSI
Lot number: W06H15
Expiration: 08/15/2024

Package: First Aid Kit
Product Number: 2980-0700
Product Description: CVS® First Aid Home
Lot number: W06H15
Expiration: 08/15/2024

Package: First Aid Kit
Product Number: 9999-2131
Product Description: Easy Care First Aid® 10 Person 2009 ANSI
Lot number: W06H15
Expiration: 08/15/2024

Package: First Aid Kit
Product Number: 9999-2132
Product Description: Easy Care First Aid® 25 Person 2009 ANSI
Lot number: W06H15
Expiration: 08/15/2024

Retailers that have any 0.9 g single-use packets or the First Aid kit lots listed above should return them to their distributor. Consumers should stop using the Easy Care first aid® AfterBurn® Cream .9g single-use packet and discard it.

In case you experienced harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: GFA Production
Brand name: Multiple brand names
Product recalled: After Burn® Cream and First Aid Kits containing After Burn Cream
Reason of the recall: Product is contaminated with Bacillus licheniformis and Bacillus sonorensis.
FDA Recall date: December 27, 2022

Source: fda.gov
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Detect, Inc. is voluntarily recalling specific lots of the Detect Covid-19 Test™, their molecular, over-the-counter test used to identify SARS-CoV-2 (the virus that causes Covid-19) in self-collected nasal swabs. The recall affects a total of 11,102 tests shipped to customers from July 26th, 2022 through August 26th,... See More 2022. The test was granted Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) on October 28, 2021. To date, Detect has not received any reports of false negative results related to the affected lots and is issuing this recall out of an abundance of caution.

There is an increased chance that the tests from the lot numbers listed below may give false negative results. Detect has conducted a thorough investigation to identify this issue and has made the decision to conduct a voluntary recall for these lots. The reliability of positive test results is not affected.

Below is a list of the affected lots. The lot number can be found on the side of each test box along with the Use By date.
Lot Number: HB264, Use By Date: 1/1/2023, Number of Tests Shipped: 7,382
Lot Number: HY263, Use By Date: 1/1/2023, Number of Tests Shipped: 1,800
Lot Number: HY264, Use By Date: 1/1/2023, Number of Tests Shipped: 1,920

There is an increased chance that the tests from the lot numbers listed below may give false negative results. Detect has conducted a thorough investigation to identify this issue and has made the decision to conduct a voluntary recall for these lots. To date, Detect has not received any reports of false negative results related to the affected lots and is issuing this recall out of an abundance of caution. The reliability of positive test results is not affected.

Detect is notifying all customers and distributors affected by the recall. Anyone in possession of any unused tests from the affected lots should dispose of the tests. The outer packaging is recyclable while all the test components can be discarded as regular trash. Detect Hubs are not affected by the recall and do not need to be discarded.

Test users who attempt to use recalled tests will be notified in the Detect App™ that the test has been recalled and may not be used.

Detect, Inc. will issue a refund* for the affected tests (as verified by Detect) upon customers’ acknowledgement of receipt of the recall-related communication and confirmation that any affected tests in possession have been disposed of.

Company name: Detect, Inc.
Brand name: Detect
Product recalled: Over the counter Covid-19 Test
Reason of the recall: There is an increased chance that the tests from the lot numbers listed below may give false negative results
FDA Recall date: December 12, 2022

Source: fda.gov
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Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), today announced a Medical Device Correction for the Omnipod® 5 Automated Insulin Delivery System because of an issue with the Omnipod 5 Controller charging port and cable. This does not impact the Omnipod 5 Pod, the Omnipod® DASH Insulin... See More Management System, the Omnipod® Insulin Management System, or compatible Android smartphone devices that have the Omnipod 5 App installed. These actions are taken voluntarily with the knowledge of the FDA. Insulet has received 24 reports that the Omnipod 5 Controller charging port (USB-C port) or cable (USB cable) are melting, deforming, or discoloring due to heat generated by a poor connection between the cable and the port.

The excess heat may cause minor burns if those areas of the Controller are touched or could lead to fire. No serious injuries have been reported to Insulet as a result of this issue.

Omnipod 5 users are being notified by email with instructions on how to detect and reduce the risk of an issue with the charging port or cable.

In case you experienced issues with this product, it is important to report it.

Company name: Insulet Corporation
Brand name: Insulet Corporation Omnipod
Product recalled: Automated Insulin Delivery System
Reason of the recall: Issue with the Omnipod 5 Controller charging port and cable
FDA Recall date: November 15, 2022

Source: fda.gov
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Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), announced on October 17, 2022, a Medical Device Correction for all Omnipod DASH® Personal Diabetes Managers (PDMs) distributed globally. This action was taken voluntarily with the knowledge of the FDA and other regulatory agencies. Insulet received reports from Omnipod... See More DASH users regarding PDM battery issues, including battery swelling and leakage, and in rare cases, extreme overheating, which has resulted in reports of fire.

The Company’s investigation determined that the Omnipod DASH PDM is at increased risk of malfunction if overcharged beyond the maximum battery voltage, which could potentially lead to serious injury or death. There have been 50 complaints about this issue. No serious injuries or deaths have been reported as a result of this potential issue. As previously communicated to Omnipod DASH users, Insulet has identified an update to the Omnipod DASH PDM that will resolve this issue.

The Company expects to begin shipping updated Omnipod DASH PDMs to all current Omnipod DASH customers in the coming months. All affected Omnipod DASH consumers are being notified by email and local mail. Insulet has been providing customers with instructions to help reduce the risk of PDM battery issues.

This Medical Device Correction does not affect Omnipod DASH Pods, the Omnipod® Insulin Management System, or the Omnipod® 5 Automated Insulin Delivery System.

In case you experienced harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance.

Company name: Insulet Corporation
Brand name: Insulet Corporation Omnipod DASH
Product recalled: Personal Diabetes Managers
Reason of the recall: Battery issue: battery swelling, leakage, and in rare cases, extreme overheating, which has resulted in reports of fire.
FDA Recall date: November 05, 2022

Source: fda.gov
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Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies for critical care and surgery, has announced a worldwide recall of affected lots of the below-referenced Gibeck® Iso-Gard® Filter products. The Gibeck® Iso-Gard® Filter is a bacterial and viral filter, intended for connection to respiratory equipment... See More in intensive care units and operating theatres to protect the equipment from potential airborne contaminants. If the filter splits or detaches during use, the functionality and efficiency of the device may be compromised, potentially resulting in a leakage and insufficient air supply to the patient with potential desaturation.

The products involved in the recall are listed below. Additional detail about how to identify the affected products is available in the recall letter.

Product Codes: 19012. Commercial Name: Iso-Gard® Filter S with Expandi-Flex/Elbow

Product Codes: 19012T. Commercial Name: Iso-Gard® Filter S with Expandi-Flex/Elbow, Tethered Cap

Product Codes: 191667-000100. Commercial Name: Filter + Catheter Mount

Product Codes: 19211; 19212. Commercial Name: Iso-Gard® Filter S

Product Codes: 19261; 19272. Commercial Name: Iso-Gard® Filter S with Expandi-Flex

Product Codes: 19261T; 19262T; 19272T. Commercial Name: Iso-Gard® Filter S with Expandi-Flex, Tethered Cap

Product Codes: 19211T; 19212T. Commercial Name: Iso-Gard® Filter S, Tethered Cap

Note: This recall is for specific lots of the above-referenced product codes.

In case you experienced harm from these products, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance.

Company name: Teleflex Incorporated
Brand name: Gibeck® and Iso-Gard®
Product recalled: Bacterial and viral filters
Reason of the recall: Bacterial and viral filters
FDA Recall date: November 04, 2022

Source: fda.gov
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Whele LLC, of Boston, MA, is voluntarily recalling its Mighty Bliss Electric Heating Pad, due to product safety concerns. Use of this product may lead to burns, mild shocks, or rashes/irritation. Product was sold via Amazon.com and Walmart.com. We received 286 complaints between July 2021 to September... See More 2022 related to the product overheating, sparking, burning, or presenting other electrical problems. 31 of these complaints reported injuries such as mild shocks, burns, and rashes or irritation.

This recall applies to 544,212 Mighty Bliss Electric Heating Pad units manufactured between 08JAN21 to 03JAN22 and distributed from 29JUL21 through 21JUL22. Model Numbers and Descriptions Below:
- MB-001 (NA-H1121B): Large (12” x 24”) Blue Electric Heating Pad
- MB-002 (NA-H21C): Extra-Large (20” x 24”) Blue Electric Heating Pad
- PE-MtyBls-HeatPad-12x24-Gry-V2(NA-H1121B): Large (12” x 24”) Grey Electric Heating Pad

The product lot number can be found directly on the heating pad listed in black text beneath the product instructions.

Company name: Whele LLC
Brand name: Mighty Bliss
Product recalled: Heating pads
Reason of the recall: Use of product may lead to burns, mild shocks, or rashes and irritation
FDA Recall date: October 24, 2022

This recall has been initiated due to product safety concerns. Use of this product may lead to electric shocks and/or skin irritation, rashes, blisters, or burns. Severe burns may result in infection or formation of scar tissue.

Customer/User Immediately cease use of the product. Distributor Immediately examine your inventory and quarantine the product subject to recall. We will be in contact to gather any remaining inventory for destruction. If you may have further distributed this product, please identify your customers and notify them within two (2) business days of this product recall.

Source: fda.gov
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Baxter International Inc. announced today it has issued an Urgent Medical Device Correction for the WatchCare Incontinence Management System due to potential for radio frequency (RF) interference with other medical devices. The WatchCare System is distributed in the United States.

This Urgent Medical Device Correction applies to... See More Centrella Bed with WatchCare product number P7900B; WatchCare System for VersaCare Bed Rev. A-J product number P00697901; WatchCare System for VersaCare Bed Rev. K product number P00697902; WatchCare System for Progressa Bed product number P00697903; and WatchCare System for Centrella Bed product number P00697905.

The WatchCare system is designed to discreetly alert the caregiver of an incontinence event. Although the WatchCare system has been developed to comply with the most recent RF standards, it radiates RF that might affect other devices in the vicinity, including devices on both patients and staff members. This RF interference could result in erroneous readings or additional malfunctions of these other devices and could therefore result in inappropriate medical intervention. Depending on the intended use of the device that malfunctions, there may be different hazardous situations that could occur. This product is manufactured by Hillrom, which was acquired by Baxter in late 2021. Baxter is also issuing an updated customer notification letter for this correction, replacing the previous letter issued on September 30, 2022. To date, interference in all cases but two is known to have occurred at distances less than one meter. There is insufficient data about distance on the remaining two reported interferences.

Of note, Baxter is informing users of the following potential hazards, though additional devices may be affected:
- Insulin pump/blood glucose sensor: Sensor readings can be affected and result in overdosing of insulin related to incorrect high glucose readings; as a precaution, users should be vigilant of any erratic or incorrect (high or low) glucose level(s) or insulin dosing events
- Fetal monitor/doppler: May cause "phantom" incorrect fetal heart tone readings up to 200 bpm; as a precaution, users should be vigilant of any erratic or incorrect (high or low) fetal heart tones
- Telemetry devices: Could cause telemetry “artifact” of unknown specificity; as a precaution, users should be vigilant of any telemetry rhythm displays that do not match patient’s clinical presentation
- Bladder scanner: May cause interference of unknown specificity; as a precaution, users should be vigilant of any potential false (elevated or low) residual urine volume readings
- Infusion injection pump: May cause interference of unknown specificity; as a precaution, users should be vigilant of any erratic or incorrect dosing events

Since this issue may affect blood glucose sensors, insulin pumps, fetal monitors, and general infusion pumps among other devices, serious harm or death may occur. This issue can affect medical devices on patients as well as staff caring for patients. No serious injuries or deaths have been reported. Users and facilities should immediately locate all affected devices and stop use of all WatchCare system accessories where possible until this functionality is temporarily disabled and while Baxter continues to work to determine the cause of this problem. Baxter will contact users to arrange for WatchCare to be temporarily disabled. Until all RF capabilities are disabled and/or all devices are removed from clinical care areas, be aware that RF emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to, insulin pumps/blood glucose sensors, fetal monitor/dopplers, infusion pumps, telemetry devices, and bladder scanners).

Please double-check all unexpected or atypical results and monitor infusions closely, if possible. Until this issue is resolved, use standard, non-RF-based, incontinence management pads. Baxter is monitoring reports of RF interference and validating the impact the WatchCare device may have on other devices in the vicinity. Baxter is also investigating improvement opportunities and will provide a follow-up communication to users once available.

Baxter is voluntarily issuing this Urgent Medical Device Correction with the knowledge of the U.S. Food and Drug Administration.

Company name: Baxter International Inc.
Brand name: WatchCare
Affected product: Incontinence management system
Reason of the Urgent Medical Device Correction: Potential for radio frequency (RF) interference with other medical devices.
FDA Recall date: October 24, 2022

Source: fda.gov
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Family Dollar 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 inadvertently shipped to certain stores on or around May 1, 2022 through June 10, 2022 due to product being stored outside... See More of labeled temperature requirements.  This notice covers the recall of Over-the-Counter Medical Devices. An earlier notice issued July 21, 2022 covered a related recall of Over-the-Counter Pharmaceutical Products. To date, Family Dollar has not received any consumer complaints or reports of illness related to this recall.  This recall is being conducted out of an abundance of caution.

- Recalled products:

900260 900260 CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT
900794 900794 LS SKYN NON LATEX LUBRICATED CONDOM 3CT
901260 901260 VERIQUICK PREGNANCY TEST 1CT
902343 902343 FIRST RESPONSE 2 CT
903409 903409 SKYN ORIGINAL NON LATEX CONDOM 12CT
903415 903415 SKYN ELITE NON LATEX CONDOM 12CT
939504 939504 VERIQUICK PREGNANCY TEST 1 CT
900752 900752 AT HOME MARIJUANA TEST STRIP
902816 902816 TROJAN ULTRA RIBBED LUBED 3CT
903756 903756 VERIQUICK PREGNANCY TEST 2 CT
999763 999763 TROJAN ULTRA THIN CONDOM LATEX 3CT
998221 998221 SKYN ELITE LARGE NON LATEX CONDOM 12CT
998869 998869 PREFERRED UTI TEST 1 CT
900265 900265 LIFESTYLES ULTRA SENSITIVE CONDOMS 12CT
900531 900531 CLEAR EYES CONTCT LENS DRPS LBRCTNG .5FO
999009 999009 B L BIOTRU MULTI PURPOSE SOLUTION 4 FLOZ
902274 902274 GS SALINE SOLUTION 12FL OZ
901443 901443 KY JELLY LUBRICANT 2 FL OZ
901960 901960 OPTI FREE REPLENISH MULTI PURPOSE 2 OZ
999801 999801 SIMPLY SALINE NASAL MIST 3.1 OZ
900457 OPTI FREE PURE MST DSINFCTNG SLTN 4FL OZ
902139 902139 DENTEMP ONE STEP .077OZ
906018 906018 FIXODENT ORG CREAM 2.4OZ
998762 998762 DRTALBOT TDDLR TTHPSTE BRSH TUTTI FRUTTI
905076 905076 CURAD STRNG WATRPRF STRIP 1IN 20CT
906312 906312 GS DENTURE CLEANSER GRN TAB 40CT
999619 999619 FIXODENT ADH CREAM ULTRA MAX HOLD 2.2OZ
999037 999037 CURAD FIRST AID KIT
903377 903377 POLIGRIP POWER MAX HOLD 2.2OZ
999417 999417 NEW SKIN LIQUID BANDAGE CLEAR .3FL OZ
900737 900737 TRVL KIT TOTHBRSH CAP PASTE IN POUCH 1CT
901239 901239 FIXODENT ORG CREAM TRAVEL .75OZ
906131 906131 POLIDENT DENTURE CLNS TAB 28CT
900334 900334 POLIGRIP ADH CREAM FREE 2.4OZ
906023 906023 GS DENTURE CLEAN OVRNT TAB 40CT
901634 901634 POLIDENT DENTURE CLEANSERS 84 CT
901777 901777 POLIDENT OVERNIGHT WHITENING TAB 28CT
906402 906402 FIXODENT ADH CREAM WITH SCOPE 2OZ
999632 999632 POLIGRIP EXTRACARE ADHESIVE CREAM 2.2OZ
900085 900085 SUPER POLIGRIP ADH CREAM .75OZ
900723 900723 POLIGRIP DENTURE ADHESIVE ORIGINAL 2.4OZ

This recall goes to the retail store level. Not all of the products listed were sent to all stores. Family Dollar has notified its affected stores asking them to check their stock immediately and to quarantine and discontinue the sale of any affected product. Customers that may have bought affected product may return such product to the Family Dollar store where they were purchased without receipt. 

This recall does not apply to Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, Vermont, Washington, Alaska, or Hawaii as Family Dollar does not have any stores in Alaska or Hawaii and no Family Dollar stores in any of the other states received any products subject to this recall. Customers should contact their physician or health care provider if they have experienced any problems that may be related to using these products.

Company name: Family Dollar
Brand name: Multiple brand names
Product recalled: Various OTC medical products
Reason of the recall: Product was stored outside of labeled temperature requirements.
FDA Recall date: September 16, 2022

Source: fda.gov
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These masks may continue to be used according to the updated instructions and labeling if patients or people in close proximity to them do not have implanted metallic medical devices or metallic objects in the body.

Royal Philips’ (NYSE: PHG; AEX: PHIA) subsidiary Philips Respironics is alerting... See More users of certain CPAP or Bi-Level PAP therapy masks with magnetic headgear clips or straps that these devices should not be used by or near patients and their household members, caregivers and bed partners who have metallic implanted devices or metallic objects (such as metallic splinters) in the body. The magnetic headgear clips are used to attach the headgear straps to the masks, which is a method that is commonly used in the sleep therapy devices industry.

This is a voluntary notification to users of specific CPAP or Bi-Level PAP therapy masks containing such magnetic clips to inform them of the updated instructions and labeling. All users should read and follow Philips Respironics’ voluntarily updated warning and added contraindication described below. This represents a new and industry-leading practice.

Contraindication: Use of the mask is contraindicated for patients and their household members, caregivers and bed partners that may be in close vicinity to patients using the masks, that have implanted devices that may be affected by magnets, including but not limited to:
- Pacemakers
- Implantable cardioverter defibrillators (ICD)
- Neurostimulators
- Magnetic metallic implants/electrodes/valves placed in upper limbs, torso, or higher (i.e., neck and head)
- Cerebral spinal fluid (CSF) shunts (e.g., ventriculo peritoneal (VP) shunt)
- Aneurysm clips
- Embolic coils
- Intracranial aneurysm intravascular flow disruption devices
- Metallic cranial plates, screws, burr hole covers, and bone substitute devices
- Metallic splinters in the eye
- Ocular implants (e.g., glaucoma implants, retinal implants)
- Certain contact lenses with metal
- Implants to restore hearing or balance that have an implanted magnet (such as cochlear implants, implanted bone conduction hearing devices, and auditory brainstem implants)
- Magnetic denture attachments
- Metallic gastrointestinal clips
- Metallic stents (e.g., aneurysm, coronary, tracheobronchial, biliary)
- Implantable ports and pumps (e.g., insulin pumps)
- Hypoglossal nerve stimulators
- Devices labeled as MR (Magnetic Resonance) unsafe
- Magnetic metallic implants not labeled for MR or not evaluated for safety in a magnetic field

Patients should stop using the affected mask if the implant/medical device is contraindicated against the mask magnets. Patients should consult their physician immediately to determine if another mask can be used for their therapy. In the interim, switch to a non-magnetic mask if available, for continued therapy.

Patients should properly dispose of the mask that has magnets after an alternative is obtained. These masks may continue to be used according to the updated instructions and labeling if patients or people in close proximity to them do not have implanted metallic medical devices or metallic objects in the body.

Warning: Magnets with a magnetic field strength of 400 mT are used in the mask. With the exception of the devices identified in the contraindication, ensure that the mask is kept at least 6 inches (approx. 15 cm) away from any other medical implants or medical devices that can be impacted by the magnetic fields to avoid possible effects from localized magnetic fields. This includes household members, caregivers, and bed partners that may be in close vicinity to patients that use the masks.

Impacted masks include: More than 17 million masks containing magnetic clips have been distributed by Philips Respironics to date. As of August 30, 2022, Philips Respironics has received 14 reports of patients suggesting that the mask magnets may have impacted their medical devices including pacemaker interference, pacemaker failure leading to replacement, need of shunt adjustment, resetting of automatic implantable cardioverter defibrillator (AICD), seizures, defibrillator shutting off periodically, arrhythmia, irregular blood pressure, change in heartbeats, and cognitive issues.

Patients may contact their Durable Medical Equipment (DME) provider, which supplied the masks affected by this notice. This voluntary medical device corrective action has been reported to the regulatory agencies in the countries where these masks are available.

In case you experienced harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance.

Company name: Royal Philips’ subsidiary Philips Respironics
Brand name: Philips
Product recalled: Certain CPAP or Bi-Level PAP therapy masks with magnetic headgear clips or straps
Reason of the recall: potential risk of serious injury

Source: fda.gov
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