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Product: Pita

Updated:

Covidien and Cardinal Health Urology and room kits and trays Update - recalled due to potential lack of sterility assurance, USA

2 months ago •source www.fda.gov

Recall notice

Nurse Assist, LLC voluntary product recall (which included products supplied to Cardinal Health used in Covidien and Cardinal Health™ brand kits and trays), Cardinal Health issued a medical device recall on December 5, 2023, for its Covidien and Cardinal Health™ brand urology and operating room-specific kits and … See More
trays that contain 0.9% sodium chloride irrigation USP and sterile water for irrigation USP supplied by Nurse Assist. Under the Nurse Assist voluntary recall, this product is being recalled due to the potential for a lack of sterility assurance which could result in non-sterile product. There have been no reports of patient harm.

In populations most at risk, such as patients who are immunocompromised, there is a possibility that the use of the affected product could potentially result in severe or life-threatening adverse events.

After reviewing the impact of the Nurse Assist recall, Cardinal Health has identified the affected Covidien and Cardinal Health™ brand codes and lot numbers, which you can see in the link below. Customers who received the listed lots were given instructions to:
1. QUARANTINE affected kits/trays.
2. ALERT clinicians of the recalled component(s).
3. AFFIX a WARNING LABEL to the front of each kit/tray so that it is clearly visible to clinicians, instructing them to remove and discard the recalled component(s).
4. NOTIFY other departments, facilities or customers within the customer’s hospital system, if they have transferred the affected kits/trays, and provide a copy of the notice and recall acknowledgement form to them.
5. RETURN their enclosed Acknowledgment Form confirming receipt of this action and the completion of over labeled product.

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. If symptoms persist, seek medical care.

Company name: Cardinal Health
Brand name: Covidien and Cardinal Health
Product recalled: Expanded list of Urology and OR room specific kits and trays
Reason of the recall: Potential lack of sterility assurance which could result in non-sterile product
FDA Recall date: February 05, 2024

Source: www.fda.gov
See Less

#recall #medicaldevices #us

Covidien and Cardinal Health Urology and room kits and trays Update - recalled due to potential lack of sterility assurance photo #1
303
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Power Outage, Langston Blvd., Arlington, VA, USA

3 months ago

A large power outage has been reported in parts of North Arlington. Much of the outage is centered around Virginia Hospital Center, between I-66 and Langston Blvd, from the Westover area to the west to near Washington-Liberty High School to the east. Another section of the outage, … See More
as seen on Dominion’s website, runs along N. Glebe Road from Langston Blvd to just after Marymount University. As of 9:15 p.m., Dominion says 3,238 customers are without power.

Outage link: outagemap.dominionenergy.com
Source: www.arlnow.com
Published: 2024-01-28
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#dominionenergy #poweroutage #langstonboulevard #arlington #virginia #us

896
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Boil Water Advisory, Corinth Road, Pittsburg, Illinois, USA

3 months ago

A boil water order has been issued for customers in the entire Corinth Water District. The order is in effect for the entire district until further notice. The district stated there is also special considerations for facilities such as hospitals, schools and nursing homes.

Source: bnnbreaking.com
Published: … See More
2024-01-15
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#boilwateradvisory #illinois #us

7
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Power Outage, U.S. 98, Hattiesburg, Miss, USA

3 months ago

A substation outage has caused almost 1,800 West Hattiesburgers in the dark for 2 hours Wednesday morning Jan 10. The affected area included several miles along the U.S. 98/Hardy Street corridor and adjacent streets in West Hattiesburg. Additionally, the traffic lights were out at the intersections of … See More
Weathersby Rd. and West Hospital Drive on Hardy Street.

Outage link: www.outageentry.com
Source: www.wdam.com
Published: 2024-01-10
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#poweroutage #ushighway98 #hattiesburg #mississippi #us

2

Leiters Health Vancomycin, Phenylephrine & Fentanyl IV Bags - recalled due to potential double drug potency, USA

3 months ago •source www.fda.gov

Recall notice

Leiters Health is voluntarily recalling 33 lots of products to the user level. The recalled batches of vancomycin IV bags, phenylephrine IV bags, and fentanyl IV bags are being recalled due to the potential for superpotency because they may contain twice the labeled amount of drug. The … See More
semi-automated IV bag filling equipment used to fill the recalled batches may not eject the IV bags properly when compressed air tanks become low or a leak was detected, causing the recalled IV bags to be dosed twice. The products were distributed nationwide to hospitals for administration in the hospital. To date, Leiters Health has not received any reports of adverse events related to this recall.

Risk Statement: There is a reasonable probability that the use of the defective vancomycin and fentanyl IV bags will be associated with life-threatening adverse events. Administration of vancomycin at twice the infusion rate has been associated with low blood pressure, including shock and cardiac arrest, as well as wheezing, shortness of breath, hives, itchy skin and skin redness. Also, overdosing of vancomycin may be associated with acute kidney injury and ototoxicity. Administration of higher doses of fentanyl than intended can result in profound respiratory depression, which may not automatically be mitigated and treated, resulting in potential for delay in care and serious adverse outcomes from hypoxia, including permanent neurologic sequelae and death. In addition to respiratory depression, fentanyl can cause serious cardiac adverse events, such as hypotension, bradycardia, and vasodilation resulting in decrease in cardiac output and cardiac arrest. In addition, administration of a higher dose of phenylephrine than intended may cause higher-than-intended blood pressures in some patients. To date, Leiters Health has not received any reports of adverse events related to this recall.

Fentanyl is an analgesic packaged in an IV bag under codes F3355 and F3342. Phenylephrine is used for perioperative hypotension, hypotension during anesthesia, and shock and is packaged in an IV bag under codes F3360 and F3352. Vancomycin is used for endocarditis and staphylococcal infections and is packaged in an IV bag under codes F3206 and F3208.

The affected products are:

- Item #F3355, FentaNYL 1000 mcg (10 mcg/mL) (as FentaNYL Citrate) PF (from API) added to 0.9% Sodium Chloride 100 mL IV bag, Lot # Expiration: 2331062 2/8/2024,
2331224 3/18/2024, 2331270 3/28/2024
- Item # F3342, FentaNYL 2500 mcg (10 mcg/mL) (as FentaNYL Citrate) PF (from API) added to 0.9% Sodium Chloride 250 mL IV bag, Lot # Expiration: 233098 1/31/2024, 2331058 2/18/2024, 2331150 3/10/2024, 2331231 3/24/2024, 2331289 3/30/2024.
- Item # F3360, Phenylephrine HCl 20 mg (80 mcg/mL) (from FDP) added to 0.9% Sodium Chloride 250 mL IV Bag, Lot # Expiration: 2330993 2/15/2024, 2331010 2/10/2024, 2331055 1/18/2024, 2331113 2/26/2024, 2331181 3/4/2024, 2331187 3/23/2024, 2331266 3/31/2024, 2331343 4/1/2024, 2331349 4/23/2024, 2331433 5/5/2024.
- Item # F3352, Phenylephrine HCl 40 mg (160 mcg/mL) (from FDP) added to 0.9% Sodium Chloride 250 mL IV Bag, Lot # Expiration: 2330939 1/30/2024, 2331032 2/3/2024, 2331112 3/19/2024, 2331190 3/26/2024, 2331429 4/28/2024.
- Item # F3206, Vancomycin HCl 1.25 g PF added to 0.9% Sodium Chloride 250 mL IV Bag, Lot # Expiration: 2331184 2/13/2024, 2331185 2/10/2024, 2331189 2/20/2024, 2331191 2/24/2024, 2331258 3/3/2024, 2331317 3/15/2024.
- Item # F3208, Vancomycin HCl 1.5 g PF added to 0.9% Sodium Chloride 250 mL IV Bag, Lot # Expiration: 2331140 2/8/2024, 2331188 2/15/2024, 2331261 3/5/2024, 2331287 3/14/2024

Leiters Health has notified its customers by a letter sent via mail, requiring signature upon receipt, and an email to all affected customers. Leiters Health is arranging for a credit for all recalled products. Customers that have product which is being recalled should cease using it and return it to Leiters Health.

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. If symptoms persist, seek medical care.

Company name: Leiters Health
Brand name: Leiters, Compounding Health
Product recalled: Vancomycin IV Bags, Phenylephrine IV Bags, and Fentanyl IV Bags
Reason of the recall: Potential for superpotent drug
FDA Recall date: January 08, 2024

Source: www.fda.gov
See Less

#recall #drugs #us

Leiters Health Vancomycin, Phenylephrine & Fentanyl IV Bags - recalled due to potential double drug potency photo #1
304
A

Power Outage, Capital Boulevard, Wake Forest, NC, USA

3 months ago

A power outage was reported at the Capital Boulevard intersection in Wake Forest on Sunday morning after a squirrel came into contact with power lines. Power has been restored to affected customers in areas around South Main and Tyler Run.

Outage link: outagemap.duke-energy.com
Source: www.wral.com
Published: 2024-01-07 See Less

#dukeenergy #poweroutage #capitalboulevard #wakeforest #northcarolina #us

109

Hospira Sodium bicarbonate & Atropine sulfate injections - recalled due to the presence of glass particulate matter, USA

4 months ago •source www.fda.gov

Recall notice

Hospira, Inc., a Pfizer company, is voluntarily recalling the lots listed in the table below of 4.2% Sodium Bicarbonate Injection, USP ABBOJECT® Glass Syringe, 5 mEq/10 mL; 8.4% Sodium Bicarbonate Injection, USP Lifeshield® ABBOJECT® Glass Syringe, 50 mEq/50 mL; and Atropine Sulfate Injection, USP Lifeshield® ABBOJECT® Glass … See More
Syringe, 1 mg/10 mL to the user level. The recall was initiated due to the potential for the presence of glass particulate matter, identified during product inspection. The products were distributed nationwide to wholesalers/hospitals/institutions in the United States and Puerto Rico from March 14, 2023 through June 29, 2023. To date, Hospira, Inc. has not received reports of any adverse events associated with this issue for these lots.

Should a patient receive an injectable product containing glass particulate matter as a result of this issue, the patient may experience serious adverse events. Potential complications related to injection of visible and subvisible inert particles include inflammation of a vein, granuloma, and blockage of blood vessels or life-threatening blood clot events. The frequency and severity of these adverse events could vary depending upon a variety of factors including the size and number of particles in the drug product, patient comorbidities (such as age, compromised organ function), and presence or absence of vascular anomalies.

The risk is reduced by the possibility of detection, as the label contains a clear statement directing the healthcare professional to visually inspect the product for particulate matter and discoloration prior to administration.

Sodium Bicarbonate Injection, USP is a sterile, nonpyrogenic, hypertonic solution of sodium bicarbonate (NaHCO3) in water for injection for administration by the intravenous route as an electrolyte replenisher and systemic alkalizer. It is indicated in the treatment of metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis. Sodium bicarbonate is further indicated in the treatment of certain drug intoxications, including barbiturates (where dissociation of the barbiturate-protein complex is desired), in poisoning by salicylates or methyl alcohol and in hemolytic reactions requiring alkalinization of the urine to diminish nephrotoxicity of hemoglobin and its breakdown products. It is also indicated in severe diarrhea which is often accompanied by a significant loss of bicarbonate.

Atropine Sulfate Injection, USP is a sterile, nonpyrogenic isotonic solution of atropine sulfate monohydrate in water for injection with sodium chloride sufficient to render the solution isotonic. It is administered parenterally by intravenous injection and is indicated for temporary blockade of severe or life-threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus or muscarinic mushroom poisoning, and to treat bradyasystolic cardiac arrest.

The NDC, Lot Number, Expiration Date, and Configuration details for the impacted products are attached.

Wholesalers, hospitals, institutions, and doctors with an existing inventory of a lot which is being recalled should discontinue use, stop distribution and quarantine the product immediately. If you have further distributed the recalled product, please notify your accounts and/or any additional locations which may have received the recalled product. Hospitals/Institutions should inform Healthcare Professionals in your organization of this recall.

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. If symptoms persist, seek medical care.

Company name: Hospira, Inc.
Brand name: Hospira
Product recalled: 4.2% Sodium bicarbonate injection, 8.4% Sodium bicarbonate injection, Atropine sulfate injection
Reason of the recall: Presence of Glass Particulate Matter
FDA Recall date: December 26, 2023

Source: www.fda.gov
See Less

#recall #drugs #us

Hospira Sodium bicarbonate & Atropine sulfate injections - recalled due to the presence of glass particulate matter photo #1
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