FDA Medical Device Recalls (openFDA)
Wilson-Cook Medical Inc: Esophageal Z-Stent Fully Coated or Uncoated Flanges, Endoprosthesis Systems with the Z Speed Introducer, Disposable Single Use Only, Rx Only, Sterile EO, Wilson-Cook Medical GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105
- Recall number
- Z-1410-04
- Recalling firm
- Wilson-Cook Medical Inc
- Product
- Esophageal Z-Stent Fully Coated or Uncoated Flanges, Endoprosthesis Systems with the Z Speed Introducer, Disposable Single Use Only, Rx Only, Sterile EO, Wilson-Cook Medical GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105
- Status
- Terminated
- Initiated
- 2003-01-30
- Posted
- 2004-08-26
- Terminated
- 2005-03-04
- Reason
- Label contains the 'Sterile EO' symbol, however the device is provided non-sterile.
- Root cause
- Other
- Action
- Consignees were notified by visit by personal company representative to the user facility on January 30, 2003.
- Quantity
- 5 units
- Distribution
- CT, HI, LA, MO, PA
- Lot, serial or model codes
- Order Number EZSP-25-10-FC, Lot Number R1688574
- 510(k) numbers
- K920218
- PMA numbers
- not on file
- Product code
- ESW
- 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
- 3e6df46828c1
- Size
- 288213574 bytes
- Published
- 2026-10-06
- Read
- 2026-10-07T03:20:25.099Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-14
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 3e6df46828c1, published 2026-10-06