Terminated

MONOJECT Prefill Heparin Lock Flush Syringe 10 Unit Heparin, 10 ml in 12 ml syringe Item code 8881580121

FDA Recall Z-0564-2011 · Posted 2010-12-09

Recalling FirmCovidien LP

Recall StatusTerminated

Product CodeNGT

Date Initiated2010-11-15

Date Terminated2015-12-04

Product Quantity54,000

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.

K032438MODIFICATION TO: MONOJET PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE, MONOJET PREFILL HEPRIN LOCK FLUSH SYRINGETyco Healthcare · 2004-06-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.