Cardinal Health Inc. has initiated a recall of around 267 million Monoject Flush Prefilled Saline Syringes (0.9% Sodium Chloride), the U.S. Food and Drug Administration announced.
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.
The recall includes 12mL Syringe, 10 mL Saline Fill with SKU 8881570121; 12mL Syringe, 3 mL Saline Fill with SKU 8881570123; and 12mL Syringe, 5 mL Saline Fill with SKU 8881570125.
The syringes can be identified by the barrel of the syringe, the case and the box. The recall applies to all lots of the products manufactured from July 2019 to June 2021 distributed between July 2019 and July 2021.
Meanwhile, Monoject 3mL syringe, 2.5mL Saline Fill is not affected by the recall. This item, SKU 8881570300, will be available for sale until inventory is depleted.
The recall was initiated after learning that there is potential for the syringe’s plunger to draw back and reintroduce air back into the syringe. The company received 37 reports of the plunger pulling back. However, no injuries have been reported to date related to the recalled products.
Cardinal Health issued the initial recall on August 4, and notified its distributors and customers by overnight delivery of a notification packet on August 5. The company is arranging for return of all recalled products.
Customers who have the affected products are urged to immediately review their inventory and quarantine and return all affected product.
In similar recalls, medical devices supplier Smiths Medical, affiliated to Smiths Group plc, in mid-June called back certain Jelco Hypodermic Needle-Pro Fixed Needle insulin syringes with skewed graduation markings.
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