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U.S. Department of Health and Human Services

Class 2 Device Recall MONOJECT Prefill Heparin Lock Flush Syringe

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  Class 2 Device Recall MONOJECT Prefill Heparin Lock Flush Syringe see related information
Date Initiated by Firm November 15, 2010
Date Posted December 09, 2010
Recall Status1 Terminated 3 on December 04, 2015
Recall Number Z-0565-2011
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, 3 ml in 12 ml syringe
Item code 8881580123
Code Information Lot # 90181964
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 2		 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 329,520
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 and Original Applicant = TYCO HEALTHCARE
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