Monoject Flush Prefilled Saline Syringes - recalled due to air reintroducing into the syringe, USA

2 years ago •source www.fda.gov

Recall notice

Monoject Flush Prefilled Saline Syringes - recalled due to air reintroducing into the syringe photo #1

United States

Company name: Cardinal Health
Brand name: Monoject
Product recalled: Flush Prefilled Saline Syringes
Reason of the recall: Products have been found to reintroduce air into the syringe after the air has been expelled
FDA Recall date: August 20, 2021
Recall details: On August 4, 2021, Cardinal Health (NYSE: CAH) initiated a nationwide recall of approximately 267 million MonojectTM Flush Prefilled Saline Syringes (0.9% Sodium Chloride). The products have been found to reintroduce air into the syringe after the air has been expelled. This could result in injection of air into blood vessels and create the potential for air embolism, which can cause serious adverse health outcomes or death.

Customers who have affected product(s) should immediately review their inventory and quarantine and return all affected product. The recall applies to all lots of the products manufactured from July 2019 to June 2021 distributed between July 2019 and July 2021. The following SKUs have been recalled:

- 12mL Syringe, 10 mL Saline Fill. SKUs: 8881570121
- 12mL Syringe, 3 mL Saline Fill. SKUs: 8881570123
- 12mL Syringe, 5 mL Saline Fill. SKUs: 8881570125

Our Monoject™ 3mL syringe, 2.5mL Saline Fill is not affected by this recall. This item, SKU 8881570300, will be available for sale until inventory is depleted.

MonojectTM Flush Prefilled Saline Syringes can be identified by the barrel of the syringe, the case and the box as shown in the pictures below.

The company has received 37 reports of the plunger pulling back. No injuries have been reported to date. Cardinal Health voluntarily recalled MonojectTM Flush Prefilled Saline Syringes after learning that there is potential for the syringe’s plunger to draw back and reintroduce air back into the syringe. Cardinal Health has notified the U.S. Food and Drug Administration of this action.

Cardinal Health notified its distributors and customers by overnight delivery of a notification packet on August 5, 2021 and is arranging for return of all recalled products.

Given the limited number of alternative prefilled saline syringe options, combined with ongoing supply, transportation and labor challenges, we anticipate that this recall may contribute to a market disruption of prefilled saline syringes.

Cardinal Health distributes this product nationwide.

Check the full recall details on www.fda.gov

Source: FDA

#medicaldevices #recall #blood #us

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ADM Animal Nutrition Chicken, Swine and Rabbit Feed Products Update - recalled due elevated levels of minerals, USA

6 days ago •source www.fda.gov

Recall notice

ADM Animal Nutrition, a division of ADM (NYSE: ADM), is expanding the recall announced on March, 30, 2024, to include the following additional products due to elevated levels of magnesium, sodium, calcium and/or phosphorus: Pen Pals® Chicken Starter-Grower (Product Nos.70009AAA46 and 70009AAA44); Pen Pals Egg Maker Complete … See More
(Product No. 70010AAAE4); MaxLean GF Concentrate (Product No. 12354AAA); ShowTec Sow Ration with Thermal Care (Product No. 12343AAA); ShowTec BB 18 BMD (Product No. 18241AGNE4); ShowTec BB 18 BMD/DBZ (Product No. 18241PLM); ShowTec Hi Fat 18 BMD (Product No. 18007AGNE4); ShowTec Lo Fat 15 BMD (Product No. 15350AGN); MoorMan's ShowTec Hi Fat 16 BMD (Product No. 16700AGN); MoorMan's ShowTec Burst Starter w/DF DEN (Product No. 24320CVW); MoorMan’s ShowTec Sale Burst w/DF CTC/DEN (Product No. 24320AYWE4); Pen Pals® Professional Show Rabbit Feed (Product No. 81657AAA); and Pen Pals Professional Rabbit 18 (Product No. 80033AAA). To see more details of each product please visit the link below.

Elevated levels of sodium can cause increased water consumption, reduced feed efficiency, egg production, and growth rate and can be fatal in chickens. Elevated levels of calcium and/or phosphorus can cause reduced feed intake and feed conversion in swine, and elevated levels of magnesium and sodium can cause loose stools, reduced growth rate, and weakness in rabbits.

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Company name: ADM Animal Nutrition
Brand name: Pen Pals, MaxLean, ShowTec, MoorMan's
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FDA Recall date: April 11, 2024

Source: www.fda.gov
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ADM Animal Nutrition Chicken, Swine and Rabbit Feed Products Update - recalled due elevated levels of minerals photo #1

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