FDA Medical Device Recalls (openFDA)
Bard Access Systems, Inc: 18F Tri-Funnel Replacement Gastrostomy Tube
- Recall number
- Z-0836-06
- Recalling firm
- Bard Access Systems, Inc
- Product
- 18F Tri-Funnel Replacement Gastrostomy Tube
- Status
- Terminated
- Initiated
- 2006-04-06
- Posted
- 2006-05-03
- Terminated
- 2009-08-12
- Reason
- Packaging for some gastrostomy tubes was labeled with incorrect balloon inflation data. An underinflated balloon may cause misplacement, slippage or premature removal of the tube. If an underinflated balloon allows the tube to be placed, or slip into, the stomal tract and not the stomach, there is a risk of infusion of fluids into the peritoneum. This carries the risk of infection.
- Root cause
- Error in labeling
- Action
- Consignees were notified by letter on 04/06/2006.
- Quantity
- 114 units
- Distribution
- Nationwide, including 4 VA facilities. No military consignees. Foreign distribution to Canada, Australia
- Lot, serial or model codes
- Product Code 000718. Lot numbers: NGPL1892, NGPL2765.
- 510(k) numbers
- ["K910492"]
- PMA numbers
- not on file
- Product code
- KGC
- Firm FEI
- 3006260740
- Firm city
- Salt Lake City
- Firm state
- UT
- 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