Z-0357-2007

Fibrin Analysis Catheter Testing System includes the component BD Vacutainer Luer-Lok Access Device...

Name: Z-0357-2007 Fibrin Analysis Catheter Testing System includes the component BD Vacutainer Luer-Lok Access Device...
Creator: Continental Medical Labs,Inc
Published: 2006-10-18
License: https://open.fda.gov/license/

Continental Medical Labs,Inc / initiated 2006-10-18 / Terminated / root cause: manufacturing process

FDA source

Continental Medical Labs,Inc began a recall of Fibrin Analysis Catheter Testing System includes the component BD Vacutainer Luer-Lok Access Device; Catalogue #364902 as a finished sterile device, Non... on 2006-10-18. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0357-2007
Status: Terminated
Initiated: 2006-10-18
Posted: 2007-01-18
Terminated: 2007-01-18
Recalling firm: Continental Medical Labs,Inc
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.
Product code: GCJ Laparoscope, General & Plastic Surgery
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.
Root cause tag: manufacturing process
FDA root cause: 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
Product codes and lots: 6071115, 607054, 607123, 607055, 607124, 607116, 607053.

Product code GCJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)