Date Initiated by Firm | October 18, 2006 |
Date Posted | January 18, 2007 |
Recall Status1 |
Terminated 3 on January 18, 2007 |
Recall Number | Z-0357-2007 |
Recall Event ID |
36655 |
Product Classification |
sample collection system - Product Code GCJ
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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 WI 53185-0306
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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 | Process control |
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 |
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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.
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