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Terminated

Ross 24 FR Magna-Port Gastrostomy Tube, Item #54738.

FDA Recall Z-0201-04 · Posted 2004-07-20

Recalling FirmRoss Products Division, Abbott Laboratories
Recall StatusTerminated
Product CodeKNT
Date Initiated2003-11-14
Date Terminated2008-10-24

Reason for Recall

An increase in reported balloon failures, which may result in tube displacement.

Firm Action

The firm notified their customers on 11/14/2003 by telephone, fax, and FedEx. Product will be returned.

Root Cause

Other

Distribution Pattern

Nationwide. Worldwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K861323REPLACEMENT GASTROSTOMY TUBEMicrovasive · 1986-12-16

Official Source

View FDA Recall →

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

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