Z-0780-03

Vision Hollow Fiber Oxygenator

Name: Z-0780-03 Vision Hollow Fiber Oxygenator
Creator: Gish Biomedical Inc
Published: 2003-03-31
License: https://open.fda.gov/license/

Gish Biomedical, Inc. / initiated 2003-03-31 / Terminated

FDA source

Gish Biomedical Inc began a recall of Vision Hollow Fiber Oxygenator on 2003-03-31. The reason FDA records is "Two reports of leakage". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0780-03
Status: Terminated
Initiated: 2003-03-31
Posted: 2003-04-22
Terminated: 2004-03-09
Recalling firm: Gish Biomedical, Inc.
Product: Vision Hollow Fiber Oxygenator
Reason for recall: Two reports of leakage.
FDA root cause: Other
Action: The firm sent recall letters by fax on March 31, 2003 requesting that the customer make arrangements to return the product.
Quantity in commerce: 1749
Distribution: Nationwide, Austria, Canada, Japan, Saudi Arabia
Product codes and lots: Lot 205200

K961530Class IIGish Reliance Oxygenator (Model Hfo)Gish Biomedical, Inc. / cleared 1996-12-05

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)