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Recall -- Firm Press Release

 

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

 

Covidien Initiates a Voluntary Recall of Certain Lots of Monoject™ Prefill Flush Syringes Sold in the United States and Bermuda

 

Contact
Consumer:
1-800-962-9888 option 1, then option 2

Media:
Lisa Clemence
508-452-4375

FOR IMMEDIATE RELEASE - August 19, 2013 - Mansfield, MA – Covidien today announced that it has initiated a voluntary recall of certain lots of Monoject™ prefill flush syringes.

Reasons for Recall: This 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 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.

Risk to Health: 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.

Affected lots:

Product IDDescriptionLot #
8881570121Monoject™ 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 10 mL Fill13A0084N
13A0094
13B0364
13C0504
13C0514
8881570123Monoject™ 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 3 mL Fill13A0084N
8881570125Monoject™ 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 5 mL Fill13A0084N
8881580121Monoject™ 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 10 mL Fill13A0084N
8881580123Monoject™ 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill13A0084N
8881580125Monoject™ 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill13A0084N
8881590121Monoject™ 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 10 mL Fill13A0084N
8881590123Monoject™ 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill13A0084N
8881590125Monoject™ 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill13A0084N
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.

Customers have been notified of this issue by letter dated August 16, 2013. To return the affected product for credit, please contact our Customer Service group at 1-800-962-9888, option 1, then option 2, and request a Return Goods Authorization Number (RGA).

Healthcare professionals and customers may report adverse events or quality problems experienced with the use of this product to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, by fax or by phone.

Contacts:

Jacqueline Strayer
Senior Vice President
Corporate Communications
508-261-8305
jacqueline.strayer@covidien.com

Coleman Lannum, CFA
Vice President
Investor Relations
508-452-4343
cole.lannum@covidien.com

 

Lisa Clemence Director
Corporate Communications
508-452-4375
lisa.clemence@covidien.com

Todd Carpenter
Senior Director
Investor Relations
508-452-4363
todd.carpenter@covidien.com

 

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