FDA Medical Device Recalls (openFDA)
Cook Endoscopy: Quantum TTC Biliary Balloon Dilation Catheter, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105
- Recall number
- Z-0520-2007
- Recalling firm
- Cook Endoscopy
- Product
- Quantum TTC Biliary Balloon Dilation Catheter, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105
- Status
- Terminated
- Initiated
- 2007-01-24
- Posted
- 2007-02-22
- Terminated
- 2012-07-26
- Reason
- The graphic label is incorrect, it lists 6mm/ 18FR. The product label is correct, it lists 10mm/ 30FR.
- Root cause
- Other
- Action
- Consignees were notified by UPS certified mail and email on/about 01/31/2007. They were instructed to return any affected product to Cook Endoscopy. A response form was attached to be completed and returned to Cook Endoscopy.
- Quantity
- 12 units
- Distribution
- Worldwide, including NY and TX in USA, Australia, Canada and India.
- Lot, serial or model codes
- Order number QBD-10X3, Lot number W2287708
- 510(k) numbers
- ["K935094"]
- PMA numbers
- not on file
- Product code
- KNQ
- Firm FEI
- 1037905
- Firm city
- Winston Salem
- Firm state
- NC
- 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