Covidien Monojet Prefill Flush Syringe Recall Issued Due to Infection Risk

A manufacturer has recalled 14 lots of prefill flush syringes due to a potential that they may be mislabeled and improperly sterilized, which could cause users to face a risk of infections or severe health consequences.  

The Covidien Monoject prefill flush syringes recall was announced by the FDA on August 19, after it was discovered the syringes were filled with water that may not have been processed through autoclave sterilization.

The syringes, containing either heparin or sodium chloride, are also equipped with a syringe cap and label that are possibly mismatched indicating the wrong product, posing an increased risk because there are no visual indicators to differentiate between products.

The prefill flush syringes are used to prevent blood clots in veins by administering anti clotting drugs such as heparin and to remove medications remaining in catheter sites. If non-sterile fluid is injected into the body it can cause life threatening infection to spread through the blood stream as well as increase the occurrence of blood clots.

The Monoject prefill flush syringes recall includes the following recalled Lot number; 13A0084N, 13A0094, 13B0364, 13C0504, 13C0514, 13A0084N, 13A0084N, 13A0084N, 13A0084N, 13A0084N, 13A0084N, 13A0084N, 13A0084N, and 13D0824N. The lots recalled include Monoject™ 0.9%, 10, and 100 Sodium Chloride Flush 12mL Syringe’s. The syringe lot number can be identified by looking on the shipper case, cartons and the individual syringes.

The FDA and the manufacturer recommend that those with recalled prefill flush syringes should separate the affected products in their inventory and contact the Customer Service group at 1-800-962-9888 to arrange a return and receive a customer credit. Customers have been notified with a letter sent out on August 16, according to Covidien.