Ross 18 FR Easy-Feed Gastrostomy Tube, Item #50114.
FDA Recall Z-0193-04 · 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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.