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

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/safety/recalls-market-withdrawals-safety-alerts/cardinal-health-issues-nationwide-recall-select-monojecttm-flush-prefilled-saline-syringes

Source: FDA