Cardinal Health initiated a nationwide recall of approximately 267 million Monoject Flush Prefilled Saline Syringes (0.9% Sodium Chloride), August 4, 2021. 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, SKU: 8881570121
- 12mL Syringe, 3 mL Saline Fill, SKU: 8881570123
- 12mL Syringe, 5 mL Saline Fill, SKU: 8881570125
The Cardinal 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.
Monoject Flush Prefilled Saline Syringes can be identified by the barrel of the syringe, the case and the box as shown in the pictures above.
The company has received 37 reports of the plunger pulling back. No injuries have been reported to date. Cardinal Health voluntarily recalled Monoject 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.
Cardinal Health distributes this product nationwide.
