Z-0678-04

Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 18 Fr., 3.5 cm length, Item Numbers: 54258 and...

Name: Z-0678-04 Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 18 Fr., 3.5 cm length, Item Numbers: 54258 and...
Creator: Ross Products Division Abbott Laboratories
Published: 2004-03-01
License: https://open.fda.gov/license/

Ross Products Division Abbott Laboratories / initiated 2004-03-01 / Terminated

FDA source

Ross Products Division Abbott Laboratories began a recall of Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 18 Fr., 3.5 cm length, Item Numbers: 54258 and 55674 on 2004-03-01. The reason FDA records is "The balloons may be defective as indicated by an increased number of early balloon failures, which may result in tube displacement from patient". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0678-04
Status: Terminated
Initiated: 2004-03-01
Posted: 2004-07-20
Terminated: 2008-10-24
Recalling firm: Ross Products Division Abbott Laboratories
Product: Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 18 Fr., 3.5 cm length, Item Numbers: 54258 and 55674.
Product code: KNT Tubes, Gastrointestinal (And Accessories)
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.
FDA root cause: Other
Action: The firm notified their customers on 3/1/2004 by telephone, fax, and FedEx. Product will be returned.
Distribution: Nationwide; Australia, New Zealand, Italy.
Product codes and lots: Lot Numbers: 83553GZ00, 85646GZ00, 87763GZ00, 88849GZ00, 89878GZ00, 89918GZ00, 90032GZ00, 90989GZ00, 92193GZ00, 93262GZ00, 94324GZ00, 82526GZ00, 85640GZ00, 86704GZ00, 87779GZ00, 89880GZ00, 90986GZ00, 91080GZ00, 93305GZ00.

Product code KNT

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)