Z-0730-04

Vision Hollow Fiber Oxygenator with GBS Coating

Name: Z-0730-04 Vision Hollow Fiber Oxygenator with GBS Coating
Creator: Gish Biomedical Inc
Published: 2004-03-04
License: https://open.fda.gov/license/

Gish Biomedical, Inc. / initiated 2004-03-04 / Terminated

FDA source

Gish Biomedical Inc began a recall of Vision Hollow Fiber Oxygenator with GBS Coating on 2004-03-04. The reason FDA records is "Customers reported leakage". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0730-04
Status: Terminated
Initiated: 2004-03-04
Posted: 2004-07-20
Terminated: 2005-01-04
Recalling firm: Gish Biomedical, Inc.
Product: Vision Hollow Fiber Oxygenator with GBS Coating
Product code: DTZ Oxygenator, Cardiopulmonary Bypass
Reason for recall: Customers reported leakage.
FDA root cause: Other
Action: Firm issued recall letters to all customers on March 4, 2004 listing lot numbers and quantities shipped to them. Returns were requested.
Quantity in commerce: 950
Distribution: NY, PA, AR, IN, IL, NH, SC, NJ, MS, MI, WI, CT, CA
Product codes and lots: Various

Product code DTZ

K023381Class IIVision Hollow Fiber Oxygenator with Guardian CoatingGish Biomedical, Inc. / cleared 2003-03-31

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)