24F Tri-Funnel Replacement Gastrostomy Tube
- Company
- Bard Access Systems, Inc.
- Recall Initiated
- April 6, 2006
- Posted
- May 3, 2006
- Terminated
- August 12, 2009
- Recall Number
- Z-0839-06
- Quantity
- 54 units
- Firm Location
- Salt Lake City, UT
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.
Distribution
Nationwide, including 4 VA facilities. No military consignees. Foreign distribution to Canada, Australia
Lot / Code Info
Product Code 00724. Lot numbers: NGPL2272, NGPL2556.
Root Cause
Error in labeling
Action Taken
Consignees were notified by letter on 04/06/2006.
More recalls by Bard Access Systems, Inc.
BD 4 Fr Single-Lumen PowerPICC Catheters, REF: 3174155, CK000540, 3174118, CK000483, 3174335, 317435...
Apr 16, 2025
Intraosseous needle and driver. Catalog/Device Name: D015151NK/BD Needle Kit for Powered Driver...
Jul 22, 2022
5 Fr IR PowerPICC Convenience Kit Catheter Dual Lumen with 70 cm Guidewire
Unit Label:
PowerPICC...
May 19, 2021