Recall Z-0567-2011 ยท NGT Saline, Vascular Access Flush
Covidien LP
MONOJECT Prefill Heparin Lock Flush Syringe 100 Unit Heparin, 10 ml in 12 ml syringe Item code 8881590121
| Date | Dec 9, 2010 (initiated Nov 15, 2010) |
| Status | Terminated |
| Reason | The heparin sodium USP used to manufacture was produced with crude heparin containing Over-Sulfated Chondroitin Sulfate. |
| Root cause | Material/Component Contamination |
| Action | 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 adfeedback@coviden.com foll |
| Quantity | 52,920 |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032438 | MODIFICATION TO: MONOJET PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE, MONOJET PREFILL HEPRIN LOCK FLUSH SYRINGE Tyco Healthcare, Jun 30, 2004 |