Covidien announced a voluntary recall of certain lots of Monoject prefill flush syringes. This recall is following the risk that a number of the syringes were filled with water but not subjected to the autoclave sterilization process.
The affected products are labeled as sodium chloride flush or heparin lock flush. The full list of recalled products can be found here. Some of these syringes have a mismatched syringe tip cap, label, filled volume, and wrapper. For the sodium chloride flush syringes with matched tip cap, syringe label, filled volume, and wrapper, there are no visual cues to identify the recalled products.
Patients can be at risk of a life-threatening infection if non-sterile fluid were to be administered. In addition, if the heparin lock flush syringe containing only water is used on peripheral or venous catheters, the patency may be compromised and clotting may occur.
Covidien has notified customers by letter dated August 16, 2013.
For more information call (800) 962-9888 or visit FDA.gov.