FDA Medical Device Recalls (openFDA)
Abbott Laboratories: 20 French Ross Over-the-Guidewire Basic Gastrostomy KIt with Reinforced Webbed Bumper for Endoscopic Removal (Basic) (list # 50728).
- Recall number
- Z-0334-05
- Recalling firm
- Abbott Laboratories
- Product
- 20 French Ross Over-the-Guidewire Basic Gastrostomy KIt with Reinforced Webbed Bumper for Endoscopic Removal (Basic) (list # 50728).
- Status
- Terminated
- Initiated
- 2004-11-12
- Posted
- 2004-12-21
- Terminated
- 2007-02-21
- Reason
- Gastrostomy and Jejunostomy primary placement kits which may contain components that may not have been adequately sterilized, were distributed.
- Root cause
- Other
- Action
- The recalling firm notified customers by letter, dated 11/12/04.
- Quantity
- 447 gastrostomy kits.
- Distribution
- The product was distributed throughout the United States and to foreign consignees located in Australia, Korea, Thailand, Venezuela, and Puerto Rico.
- Lot, serial or model codes
- Lots 13959GZ00, 90997GZ00.
- 510(k) numbers
- ["K915110"]
- PMA numbers
- not on file
- Product code
- LNO
- Firm FEI
- 1527460
- Firm city
- Columbus
- Firm state
- OH
- 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