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Terminated

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.

FDA Recall Z-0357-2007 · Posted 2007-01-18

Recalling FirmContinental Medical Labs,Inc
Recall StatusTerminated
Product CodeGCJ
Date Initiated2006-10-18
Date Terminated2007-01-18
Product Quantity840 kits

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.

Firm Action

Consignee was notified by certified mail on 10/19/06.

Root Cause

Process control

Distribution Pattern

Product was distributed to one consignee located in Wisconsin

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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