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Terminated

Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 24 Fr., 2.7 cm length, Item Numbers: 54222 and 55717.

FDA Recall Z-0699-04 · Posted 2004-07-20

Recalling FirmRoss Products Division Abbott Laboratories
Recall StatusTerminated
Product CodeKNT
Date Initiated2004-03-01
Date Terminated2008-10-24

Reason for Recall

The balloons may be defective as indicated by an increased number of early balloon failures, which may result in tube displacement from patient.

Firm Action

The firm notified their customers on 3/1/2004 by telephone, fax, and FedEx. Product will be returned.

Root Cause

Other

Distribution Pattern

Nationwide; Australia, New Zealand, Italy.

Official Source

View FDA Recall →

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

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