Recall -- Firm Press Release
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Covidien Initiates a Voluntary Recall of Certain Lots of Monoject™ Prefill Flush Syringes Sold in the United States and Bermuda
1-800-962-9888 option 1, then option 2
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.
|Product ID||Description||Lot #|
|8881570121||Monoject™ 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 10 mL Fill||13A0084N|
|8881570123||Monoject™ 0.9% 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|
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.
- Online: http://www.fda.gov/MedWatch/report.htm
- Regular Mail: use postage-paid FDA form 3500 available at: http://www.fda.gov/MedWatch/getforms.htm.
Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
- Fax: 1-800-332-0178
- Phone: 1-800-332-1088
Senior Vice President
Coleman Lannum, CFA
Lisa Clemence Director
Recalled Product Photos Are Also Available on FDA's Flickr Photostream.