Recall Z-0838-06 ยท KGC Tube, Gastro-Enterostomy
Bard Access Systems, Inc
22F Tri-Funnel Replacement Gastrostomy Tube
| Date | May 3, 2006 (initiated Apr 6, 2006) |
| Status | Terminated |
| 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 | 236 units |
| Distribution | Nationwide, including 4 VA facilities. No military consignees. Foreign distribution to Canada, Australia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K910492 | BARD REPLACEMENT GASTROSTOMY TUBE C.R. Bard, Inc., Jul 24, 1991 |