FDA Medical Device Recalls (openFDA)
Laborie Medical Technologies Cor: Laborie Medical Technologies Urodynamic Catheters, Twin Lumen 6 Fr , 40cm For Cystometry. Catalog Number: CAT-206.
- Recall number
- Z-1711-2009
- Recalling firm
- Laborie Medical Technologies Cor
- Product
- Laborie Medical Technologies Urodynamic Catheters, Twin Lumen 6 Fr , 40cm For Cystometry. Catalog Number: CAT-206.
- Status
- Terminated
- Initiated
- 2009-04-09
- Posted
- 2009-07-21
- Terminated
- 2009-08-20
- Reason
- 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
- 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
- 28 boxes (10's)
- Distribution
- Nationwide Distribution -- CA, GA, IL, KS, MD, PA, OH, OK, UT and WA.
- Lot, serial or model codes
- Lot Number: 82484.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- EXQ
- Firm FEI
- 3017448360
- Firm city
- Williston
- Firm state
- VT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28