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Terminated

Laborie Medical Technologies Urodynamic Catheters, Twin Lumen 6 Fr , 40cm For Cystometry. Catalog Number: CAT-206.

FDA Recall Z-1711-2009 · Posted 2009-07-21

Recalling FirmLaborie Medical Technologies Cor
Recall StatusTerminated
Product CodeEXQ
Date Initiated2009-04-09
Date Terminated2009-08-20
Product Quantity28 boxes (10's)

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.

Firm 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.

Root Cause

Packaging process control

Distribution Pattern

Nationwide Distribution -- CA, GA, IL, KS, MD, PA, OH, OK, UT and WA.

Official Source

View FDA Recall →

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

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