Class 2 Device Recall MONOJECT Prefill Heparin Lock Flush Syringe

• Date Initiated by Firm: November 15, 2010
• Date Posted: December 09, 2010
• Recall Status: Terminated on December 04, 2015
• Recall Number: Z-0566-2011
• Recall Event ID: 57315
• 510(K)Number: K032438
• Product Classification: Saline, vascular access flush - Product Code NGT
• Product: MONOJECT Prefill Heparin Lock Flush Syringe 10 Unit Heparin, 5 ml in 12 ml syringe Item code 8881580125
• Code Information: Lot # 9081974, 9081984, 9082034, 9082074, 9082084
• Recalling Firm/ Manufacturer: Covidien LP; 15 Hampshire St; Mansfield MA 02048-1113
• For Additional Information Contact: 508-261-8000
• Manufacturer Reason for Recall: The heparin sodium USP used to manufacture was produced with crude heparin containing Over-Sulfated Chondroitin Sulfate.
• FDA Determined 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 following the instructions on the form. For questions customers were to contact Customer Service at 1-800-962-9888
• Quantity in Commerce: 1,356,480
• 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = NGT