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Terminated

20F Tri-Funnel Replacement Gastrostomy Tube

FDA Recall Z-0837-06 · Posted 2006-05-03

Recalling FirmBard Access Systems, Inc
Recall StatusTerminated
Product CodeKGC
Date Initiated2006-04-06
Date Terminated2009-08-12
Product Quantity110 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.

K910492BARD REPLACEMENT GASTROSTOMY TUBEC.R. Bard, Inc. · 1991-07-24

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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