Covidien recalled certain lots of Monoject prefill flush syringes due to the risk that a number of the syringes were filled with water but not subjected to the autoclave sterilization process. These products are labeled as either sodium chloride flush or heparin lock flush. Some of these syringes have the mismatched syringe tip cap, syringe label, filled volume, and wrapper. However, 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.
If non-sterile fluid is administered there is a health risk of life-threatening infection to the blood stream or other areas. Also 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 and clotting may occur. This could result in non-functional intravenous access requiring the device to be replaced. Only Monoject prefill flush syringes from particular lot numbers are affected by this recall. The lot numbers can be found on the shipper case, carton and individual syringes.
Some of the products, if incorrectly labeled, could result in patients receiving drugs that were not prescribed, which could result in allergic reactions or other undesired effects. Pregnant women could receive a drug that they should not take or, as a result of receiving an incorrect medication, patients may not receive proper treatment of their disease or condition. This may pose serious or life-threatening risk to a patient’s health.
See the Recall
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication