Medical Advisory #416: Voluntary Recall Issued for Certain Lots of Monoject (TM) Prefill Flush Syringes

Aug 23, 2013

Covidien, a healthcare products company, initiated a voluntary recall of certain lots of Monoject^TM prefill flush syringes due to the syringes being filled with water that had not been subjected to their autoclave sterilization process.

These products can be either labeled as "sodium chloride" flush or "heparin lock" flush. Some of the syringes have a mismatched syringe tip cap, syringe label, fill volume and wrapper. However, the company states that "for the sodium chloride flush syringes with matched tip cap, syringe label, filled volume and wrapper, there are no visual cues for the clinician to identify the problematic products."

These syringes are primarily used with peripheral PICC lines, port catheter lines, and Broviac and Hickman lines to flush the lines after use. If non-sterile fluid is administered to an individual, there is a risk of life-threatening infection in the blood stream or other parts of the body. Also if an individual uses the heparin lock flush syringe which contains instead only water on peripheral or central venous catheters, the patency of the intravascular device may not be maintained, and clotting may occur. This could result in non-functional intravenous access, requiring the device to be replaced.

The affected lots are as follows:

Product ID	Description	Lot #
8881570121	Monoject^TM 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 10 mL Fill	13A0084N 13A0094 13B0364 13C0504 13C0514
8881570123	Monoject^TM 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 3 mL Fill	13A0084N
8881570125	Monoject^TM 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 5 mL Fill	13A0084N
8881580121	Monoject^TM 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 10 mL Fill	13A0084N
8881580123	Monoject^TM 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill	13A0084N
8881580125	Monoject^TM 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill	13A0084N
8881590121	Monoject^TM 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 10 mL Fill	13A0084N
8881590123	Monoject^TM 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill	13A0084N
8881590125	Monoject^TM 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill	13A0084N 13D0824N

According to the company's release, only Monoject^TM prefill flush syringes from the lot numbers above are affected by this action. The lot numbers can be found on the shipper case, carton and individual syringe. These products were only sold in the United States and Bermuda.

NHF feels that it is important to inform the community of this recall and suggests that if you have any products from these affected lots, you contact your hemophilia treatment center (HTC) or homecare provider to request a replacement.

It is unclear whether Covidien manufactures any of the prefilled syringes that are supplied with factor products. NHF is contacting the factor manufacturers and will issue an updated medical advisory if necessary.

Healthcare professionals and consumers may report any adverse events related to the use of these products to FDA's Med Watch Adverse Reporting program by calling 1-800-332-1088 or via their webpage at http://www.fda.gov/medwatch/report.htm

PHYSICIANS: Please distribute this information to all providers in your area who treat patients with hemophilia. CHAPTERS: Please distribute this information to your membership.

Please sign up for the Patient Notification System (PNS) to be notified directly about the latest recall or withdrawal of recombinant and plasma products. The system is confidential and time sensitive. It is administered by an independent third-party organization and is free of charge. To enroll in the PNS, please call (888) UPDATE-U or go online at http://www.patientnotificationsystem.org

This material is provided for your general information only. NHF does not give medical advice or engage in the practice of medicine. NHF under no circumstances recommends treatment for specific individuals and in all cases recommends that you consult your physician or local hemophilia treatment center before pursuing any course of treatment.