Z-1711-2009

Laborie Medical Technologies Urodynamic Catheters, Twin Lumen 6 Fr , 40cm For Cystometry. Catalog Number...

Name: Z-1711-2009 Laborie Medical Technologies Urodynamic Catheters, Twin Lumen 6 Fr , 40cm For Cystometry. Catalog Number...
Creator: Laborie Medical Technologies Cor
Published: 2009-04-09
License: https://open.fda.gov/license/

Abbott Medical / initiated 2009-04-09 / Terminated / root cause: packaging

FDA source

Laborie Medical Technologies Cor began a recall of Laborie Medical Technologies Urodynamic Catheters, Twin Lumen 6 Fr , 40cm For Cystometry. Catalog Number: CAT-206 on 2009-04-09. The reason FDA records is "Laborie Medical Technologies reports that there was a mix up in the labeling and packaging of their Urodynamic Catheters. There were 8Fr catheters mixed inside the 6Fr catheter packages". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1711-2009
Status: Terminated
Initiated: 2009-04-09
Posted: 2009-07-21
Terminated: 2009-08-20
Recalling firm: Abbott Medical
Product: Laborie Medical Technologies Urodynamic Catheters, Twin Lumen 6 Fr , 40cm For Cystometry. Catalog Number: CAT-206.
Product code: EXQ Cystometer, Electrical Recording
Reason for recall: Laborie Medical Technologies reports that there was a mix up in the labeling and packaging of their Urodynamic Catheters. There were 8Fr catheters mixed inside the 6Fr catheter packages.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Laborie Medical Technologies notified customers by telephone/email beginning April 10, 2009 advising them of the mislabelled product. For further questions, contact Laborie Medical Technologies at 1-800-522-6743.
Quantity in commerce: 28 boxes (10's)
Distribution: Nationwide Distribution -- CA, GA, IL, KS, MD, PA, OH, OK, UT and WA.
Product codes and lots: Lot Number: 82484.

Product code EXQ

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)