MONOJECT Prefill Heparin Lock Flush Syringe 10 Unit Heparin, 5 ml in 12 ml syringe Item code 8881580125
FDA Recall Z-0566-2011 · Posted 2010-12-09
Recalling FirmCovidien LP
Recall StatusTerminated
Product CodeNGT
Date Initiated2010-11-15
Date Terminated2015-12-04
Product Quantity1,356,480
Reason for Recall
The heparin sodium USP used to manufacture was produced with crude heparin containing Over-Sulfated Chondroitin Sulfate.
Firm 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 [email protected] following the instructions on the form.
For questions customers were to contact Customer Service at 1-800-962-9888
Root Cause
Material/Component Contamination
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.