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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
Fibrin analysis Catheter Testing System		see related information
Date Posted January 18, 2007
Recall Number Z-0357-2007
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
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.
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
 
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