24F Tri-Funnel Replacement Gastrostomy Tube
FDA Recall Z-0839-06 · Posted 2006-05-03
Recalling FirmBard Access Systems, Inc
Recall StatusTerminated
Product CodeKGC
Date Initiated2006-04-06
Date Terminated2009-08-12
Product Quantity54 units
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.
Firm Action
Consignees were notified by letter on 04/06/2006.
Root Cause
Error in labeling
Distribution Pattern
Nationwide, including 4 VA facilities. No military consignees. Foreign distribution to Canada, Australia
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.