Voluntary Recall Announcement for Select MonojectTM Prefilled Saline Syringes

In close coordination with the U.S. Food and Drug Administration (FDA), we have issued a voluntary recall for three SKUs in the Monoject™ Flush Prefilled Syringes (0.9% Sodium Chloride) portfolio, which are intended for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices. The recall applies to all lots of the products distributed between July 2019 and July 2021.

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.

We are issuing the voluntary recall after learning that there is potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe. If a clinician is not aware of air being reintroduced into the syringe, air could be inadvertently pushed into the vascular system creating the potential for an air embolism. At this time, Cardinal Health has not received any reports of patient harm or injury related to this issue.

These syringes are different from syringes used to administer COVID-19, flu and other vaccines.

Starting August 5, 2021, customers who may have received affected products will receive notification packets. Customers are instructed to:

• review all inventory for affected products;
• segregate all on-hand products;
• communicate this notice to all clinical staff to ensure awareness of this product issue;
• for the impacted Presource® kits, over labels will be provided to customers. The over labels can be adhered to the kits at the customer's facility;
• return the acknowledgement form via fax or email;
• and contact Customer Service to arrange for return and credits of any affected 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. We are actively working to address the disruption and support customers' needs with locating alternative supply and we suggest that clinicians work with their facility to determine alternative fill methods.

As always, our top priority is the safety of patients, our customers and their healthcare workers. We are committed to helping ensure quality products for our customers and the patients they serve and understand and apologize for any disruption this recall causes in the healthcare system.

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