Covidien recalls some lots of Monoject prefill flush syringes

Aug. 20, 2013 at 12:02 AM   |   0 comments

WASHINGTON, Aug. 20 (UPI) -- Covidien, a healthcare products producer, initiated a voluntary recall of certain lots of Monoject prefill flush syringes, U.S. government officials say.

The U.S. Food and Drug Administration says the recall is being conducted 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 a 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, the FDA says.

"If non-sterile fluid is administered there is a health risk of life-threatening infection to the blood stream or other areas," the FDA said in a statement.

"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."

The affected lots include:

-- 8881570121 Monoject 0.9 percent Sodium Chloride Flush Syringe, 12 mL Syringe with 10 mL Fill 13A0084N, 13A0094, 13B0364, 13C0504, 13C0514.

-- 8881570123 Monoject 0.9 percent Sodium Chloride Flush Syringe, 12 mL Syringe with 3 mL Fill 13A0084N.

-- 8881570125 Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 5 mL Fill 13A0084N.

-- 8881580121 Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 10 mL Fill 13A0084N.

-- 8881580123 Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill 13A0084N.

-- 8881580125 Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill 13A0084N.

-- 8881590121 Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 10 mL Fill 13A0084N.

-- 8881590123 Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill 13A0084N.

-- 8881590125 Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill 13A0084N, 13D0824N.

Only Monoject prefill flush syringes from the lot numbers listed above are affected by this action. The lot numbers can be found on the shipper case, carton and individual syringes. Customers are required to identify, segregate and return any affected products in their inventory, the FDA says.

Customers were notified of this issue by letter dated this past Friday. To return the affected product for credit, please contact the customer service group at 1-800-962-9888.

© 2013 United Press International, Inc. All Rights Reserved. Any reproduction, republication, redistribution and/or modification of any UPI content is expressly prohibited without UPI's prior written consent.
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