FDA Medical Device Recalls (openFDA)
Ross Products Division, Abbott Laboratories: Ross 16 FR Magna-Port Gastrostomy Tube, Item #51360.
- Recall number
- Z-0197-04
- Recalling firm
- Ross Products Division, Abbott Laboratories
- Product
- Ross 16 FR Magna-Port Gastrostomy Tube, Item #51360.
- Status
- Terminated
- Initiated
- 2003-11-14
- Posted
- 2004-07-20
- Terminated
- 2008-10-24
- Reason
- An increase in reported balloon failures, which may result in tube displacement.
- Root cause
- Other
- Action
- The firm notified their customers on 11/14/2003 by telephone, fax, and FedEx. Product will be returned.
- Quantity
- not on file
- Distribution
- Nationwide. Worldwide.
- Lot, serial or model codes
- Lot Numbers: 01520GZ00, 03615GZ00, 06710GZ00, 88835GZ00, 90983GZ00, 91074GZ00, 91129GZ00, 92212GZ00, 96442GZ00
- 510(k) numbers
- ["K861323"]
- PMA numbers
- not on file
- Product code
- KNT
- Firm FEI
- 1000136098
- 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