FDA Medical Device Recalls (openFDA)
Cook Endoscopy: Fusion OMNI ERCP Catheter, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105
- Recall number
- Z-0160-2007
- Recalling firm
- Cook Endoscopy
- Product
- Fusion OMNI ERCP Catheter, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105
- Status
- Terminated
- Initiated
- 2006-10-05
- Posted
- 2006-11-08
- Terminated
- 2006-12-15
- Reason
- Injection through the flush port of these ERCP catheters may be compromised due to omission of a manufacturing activity.
- Root cause
- Process control
- Action
- Cook Ireland customers were notified by letter via email on 10/13/2006.
- Quantity
- 20 units
- Distribution
- Worldwide.
- Lot, serial or model codes
- Lot number W2243511, Expiration date 7/12/2009
- 510(k) numbers
- ["K932205"]
- PMA numbers
- not on file
- Product code
- KOG
- 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