Z-0203-04

Ross 18 FR Introducer Gastrostomy Kit with Brown Mueller T-Fastener Set, Item #50190

Name: Z-0203-04 Ross 18 FR Introducer Gastrostomy Kit with Brown Mueller T-Fastener Set, Item #50190
Creator: Ross Products Division, Abbott Laboratories
Published: 2003-11-14
License: https://open.fda.gov/license/

Ross Products Division Abbott Laboratories / initiated 2003-11-14 / Terminated

FDA source

Ross Products Division, Abbott Laboratories began a recall of Ross 18 FR Introducer Gastrostomy Kit with Brown Mueller T-Fastener Set, Item #50190 on 2003-11-14. The reason FDA records is "An increase in reported balloon failures, which may result in tube displacement". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0203-04
Status: Terminated
Initiated: 2003-11-14
Posted: 2004-07-20
Terminated: 2008-10-24
Recalling firm: Ross Products Division Abbott Laboratories
Product: Ross 18 FR Introducer Gastrostomy Kit with Brown Mueller T-Fastener Set, Item #50190.
Product code: KNT Tubes, Gastrointestinal (And Accessories)
Reason for recall: An increase in reported balloon failures, which may result in tube displacement.
FDA root cause: Other
Action: The firm notified their customers on 11/14/2003 by telephone, fax, and FedEx. Product will be returned.
Distribution: Nationwide. Worldwide.
Product codes and lots: Lot Numbers: 02565GZ00, 03600GZ00, 04643GZ00, 05676GZ00, 06719GZ00, 89942GZ00, 90015GZ00, 91105GZ00, 92199GZ00, 93261GZ00, 94322GZ00 95410GZ00, 96470GZ00

Product code KNT

K861323Class IIReplacement Gastrostomy TubeMicrovasive / cleared 1986-12-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)