Covidien Plc just announced a recall of 14 lots of its Monoject™ prefill flush syringes that were sold in the United States and Bermuda.
The recall was implemented because the syringes contained non-sterilized water, which could lead to life-threatening infections. Some syringes, meant to administer saline or the blood thinner, drug heparin, also had mismatched caps, labels, and wrappers, Covidien said, according to Reuters. The syringes are used to reduce blood clots in the veins and to remove medication remaining at the site of catheter insertion. Should the heparin syringe that only contains water be used, catheter clogging can occur, Reuters reported.
The U.S. Food and Drug Administration (FDA) noted that the syringes were not sterilized via the autoclave process and the products also have mismatched fill volumes. Also, there are no visual cues for the clinician to identify the problematic products for the sodium chloride flush syringes with matched tip cap, syringe label, filled volume, and wrapper.
Health risk of life-threatening infection can occur to the blood stream or other areas and if the clinician uses the heparin lock flush syringe containing only water on peripheral or venous catheters, the patency of the intravascular device may not be maintained, which is what can lead to clotting and a non-functional intravenous access, the agency noted. The affected lots are:
- 8881570121: Monoject™ 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 10 mL Fill
- 8881570123” Monoject™ 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 3 mL Fill
- 8881570125: Monoject™ 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 5 mL Fill
- 8881580121: Monoject™ 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 10 mL Fill
- 8881580123: Monoject™ 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill
- 8881580125: Monoject™ 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill
- 8881590121: Monoject™ 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 10 mL Fill
- 8881590123: Monoject™ 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill
- 8881590125: Monoject™ 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill
The lot numbers can be found on the shipper case, carton, and individual syringes. Customers should identify, segregate, and return the recalled products in their inventory. Customers have been notified of this issue in writing, by letter, dated August 16, 2013. Covidien Customer Service group may be reached, toll-free, at 1.800.962.9888. Choose “Option 1,” then choose “Option 2,” and then request a “Return Goods Authorization Number [RGA]).
