22F Tri-Funnel Replacement Gastrostomy Tube
FDA device recall Z-0838-06 · posted 2006-05-03 · Terminated
Recall details
- Recalling firm
- Bard Access Systems, Inc
- Reason for recall
- 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.
- Action taken
- Consignees were notified by letter on 04/06/2006.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- KGC
- Quantity affected
- 236 units
- Distribution
- Nationwide, including 4 VA facilities. No military consignees. Foreign distribution to Canada, Australia
- Date initiated
- 2006-04-06
- Date posted
- 2006-05-03
- Date terminated
- 2009-08-12
- Location
- Salt Lake City, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BARD REPLACEMENT GASTROSTOMY TUBE (K910492) | C.R. Bard, Inc. | 1991-07-24 |