Class 3 Device Recall Urodynamic Catheters

• Date Initiated by Firm: April 09, 2009
• Date Posted: July 21, 2009
• Recall Status: Terminated on August 20, 2009
• Recall Number: Z-1711-2009
• Recall Event ID: 52431
• Product Classification: Cystometer, electrical recording - Product Code EXQ
• Product: Laborie Medical Technologies Urodynamic Catheters, Twin Lumen 6 Fr , 40cm For Cystometry. Catalog Number: CAT-206.
• Code Information: Lot Number: 82484.
• Recalling Firm/ Manufacturer: Laborie Medical Technologies Cor; 400 Avenue D Ste 10; Williston VT 05495-7828
• Manufacturer 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.
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.