FDA Medical Device Recalls (openFDA)
Wilson-Cook Medical Inc: Quantum TTC Biliary Balloon Dilator
- Recall number
- Z-1292-03
- Recalling firm
- Wilson-Cook Medical Inc
- Product
- Quantum TTC Biliary Balloon Dilator
- Status
- Terminated
- Initiated
- 2003-09-15
- Posted
- 2003-10-15
- Terminated
- 2004-04-08
- Reason
- The product was labeled 'esophageal', but contained a 'biliary' ballon
- Root cause
- Other
- Action
- The consignees were notified of the recall via letter on September 15, 2003. The bottom portion of the recall communication is to be returned indicating amount of product being returned or indicating no product was to be returned.
- Quantity
- 127 devices
- Distribution
- Nationwide. CA, FL, IL, IN, IA, KS, LA, MI, MO, NJ, NC, OH, OK, TX, VA, WA, WI and foreign accounts in Canada, England, India, Japan, Korea, Mexico and Uruguary,
- Lot, serial or model codes
- W1790782, W1786043, W1783537, W1782956, W1782310, W1781860, W1777960, W1777449
- 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