MONOJECT Prefill Heparin Lock Flush Syringe 10 Unit Heparin, 3 ml in 12 ml syringe Item code 8881580123
Recall
- Recall Number
- Z-0565-2011
- Event Number
- 57315
- FEI Number
- 1282497
- Product Code
- NGT
- Status
- Terminated
- Root Cause
- Material/Component Contamination
- Initiated
- November 15, 2010
- Posted
- December 9, 2010
- Terminated
- December 4, 2015
- Address
- LP 15 Hampshire St, Covidien, Mansfield, MA, 02048-1113
Description
MONOJECT Prefill Heparin Lock Flush Syringe 10 Unit Heparin, 3 ml in 12 ml syringe Item code 8881580123
The heparin sodium USP used to manufacture was produced with crude heparin containing Over-Sulfated Chondroitin Sulfate.
COVIDEN sent an URGENT PRODUCT RECALL letter dated November 12, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and in-use stock to determine if they had any units of the affected product and quarantine the product immediately. Distributors were instructed to notify their customers immediately of the URGENT PRODUCT RECALL letter. Customers were to fill out the enclosed response form and return it by fax to (203) 822-6009 or email to [email protected] following the instructions on the form. For questions customers were to contact Customer Service at 1-800-962-9888
Nationwide Distribution including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, LA, KS, KY, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV and Bermuda
329,520