Z-0838-06

22F Tri-Funnel Replacement Gastrostomy Tube

Name: Z-0838-06 22F Tri-Funnel Replacement Gastrostomy Tube
Creator: Bard Access Systems, Inc
Published: 2006-04-06
License: https://open.fda.gov/license/

Bard Access Systems, Inc. / initiated 2006-04-06 / Terminated / root cause: labeling and UDI

FDA source

Bard Access Systems, Inc began a recall of 22F Tri-Funnel Replacement Gastrostomy Tube on 2006-04-06. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0838-06
Status: Terminated
Initiated: 2006-04-06
Posted: 2006-05-03
Terminated: 2009-08-12
Recalling firm: Bard Access Systems, Inc.
Product: 22F Tri-Funnel Replacement Gastrostomy Tube
Product code: KGC Tube, Gastro-Enterostomy
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.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Consignees were notified by letter on 04/06/2006.
Quantity in commerce: 236 units
Distribution: Nationwide, including 4 VA facilities. No military consignees. Foreign distribution to Canada, Australia
Product codes and lots: Product Code 000722. Lot number NGPL1161.

Product code KGC

K910492Class IIBard Replacement Gastrostomy TubeC.R. Bard, Inc. / cleared 1991-07-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)