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U.S. Department of Health and Human Services

Class 2 Device Recall Fibrin analysis Catheter Testing System

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 Class 2 Recall
Fibrin analysis Catheter Testing System
see related information
Date Posted January 18, 2007
Recall Status1 Terminated on January 18, 2007
Recall Number Z-0357-2007
Recall Event ID 36655
Product Classification Laparoscope, General & Plastic Surgery - Product Code GCJ
Product Fibrin Analysis Catheter Testing System includes the component BD Vacutainer Luer-Lok Access Device; Catalogue #364902 as a finished sterile device, Non Pyrogenic in unopened undamaged package, Disposable/ Single use/ Do Not Reuse; for use with multi lumen; (4 Venous Catheter sizes) 20 cm. 12 fr. Central; 16 cm. 7-7.5-8 fr. Central; 20 cm 7.7.5-8 fr Central; 16cm 12 fr. Central. Manufactured in the USA for: CRS Medical Diagnostics, Inc., Pewaukee, WI.
Code Information 6071115, 607054, 607123, 607055, 607124, 607116, 607053.
Recalling Firm/
Manufacturer
Continental Medical Labs,Inc
813 Ela Ave / PO Box 306
Waterford, Wisconsin 53185-0306
Manufacturer Reason
for Recall
Fibrin Analysis Catheter Testying System contains the ''Luer Lok Access Device'' that fails to lock securely to certain catheter devices because the male luer taper surface is not within the specification of the taper.
FDA Determined
Cause 2
DESIGN: Device Design
Action Consignee was notified by certified mail on 10/19/06.
Quantity in Commerce 840 kits
Distribution Product was distributed to one consignee located in Wisconsin
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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