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U.S. Department of Health and Human Services

Class 2 Device Recall Kendall/Tyco Monoject

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  Class 2 Device Recall Kendall/Tyco Monoject see related information
Date Initiated by Firm March 28, 2008
Date Posted May 09, 2008
Recall Status1 Terminated 3 on June 25, 2012
Recall Number Z-1596-2008
Recall Event ID 47436
510(K)Number K032438  
Product Classification Heparin Access Flush - Product Code NZW
Product Tyco Healthcare Tyco HealthcareMonoject Prefill 10U/mL Heparin
Lock Flush Syringe 5mL
REF # 8881580125Tyco Healthcare, Mansfield, MA 02048
Code Information Lot Numbers: 7051524; 7082274; 7113164; 7113174
Recalling Firm/
Manufacturer		 Covidien LP
15 Hampshire St
Mansfield MA 02048-1113
For Additional Information Contact SAME
508-261-8000
Manufacturer Reason
for Recall		 Scientific Protein Laboratories (SPL), disclosed that two lots of Heparin Sodium, USP Active Pharmaceutical Ingredient has a heparin-like contaminant
FDA Determined
Cause 2		 Material/Component Contamination
Action Tyco Healthcar notifed customers by letter sent via US Postal Service beginning 3/28/08, through 4/1/08. The letter requests that they immediately stop using and return the product. Distributors are requested to in-turn notify their customers. An instruction sheet was attached for product return and replacement. All customers are required to respond to the notice regardless of remaining inventory. .
Quantity in Commerce 1,157,580 units
Distribution Nationwide Distribution
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 = NZW and Original Applicant = TYCO HEALTHCARE
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