Z-0519-06

The GISH Vision Hollow Fiber Oxygenator with GBS coating (a non-leaching heparin coating) is a sterile...

Name: Z-0519-06 The GISH Vision Hollow Fiber Oxygenator with GBS coating (a non-leaching heparin coating) is a sterile...
Creator: Gish Biomedical Inc
Published: 2005-11-28
License: https://open.fda.gov/license/

Gish Biomedical, Inc. / initiated 2005-11-28 / Terminated

FDA source

Gish Biomedical Inc began a recall of The GISH Vision Hollow Fiber Oxygenator with GBS coating (a non-leaching heparin coating) is a sterile, non-pyrogenic, single use, disposable, extracorporeal... on 2005-11-28. The reason FDA records is "Gish received four reports of potential leakage. All reports were associated with GBS coating. There was no patient injury reported". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0519-06
Status: Terminated
Initiated: 2005-11-28
Posted: 2006-02-14
Terminated: 2007-06-21
Recalling firm: Gish Biomedical, Inc.
Product: The GISH Vision Hollow Fiber Oxygenator with GBS coating (a non-leaching heparin coating) is a sterile, non-pyrogenic, single use, disposable, extracorporeal device designed to be used in an extracorporeal blood circuit to control exchange of gases. It is intended for the supply of oxygen to, and the removal of carbon dioxide from, the blood of humans. An integral heat exchanger is included which is intended to control the temperature of the blood.
Product code: DTZ Oxygenator, Cardiopulmonary Bypass
Reason for recall: Gish received four reports of potential leakage. All reports were associated with GBS coating. There was no patient injury reported.
FDA root cause: Other
Action: The firm faxed all initial consignees a letter notifying them of the recall and the affected lots involved. 11/14/2005 The consignee was instructed to immediately inspect their inventory, and if any units of the affected product remain, the consignee is to contact Gish Biomedical Customer Service at 866-221-9911. The consignee is to provide catalogue number, lot number and quantity and state the reason for replacement is the recall letter. Customer Service will, at the same time, issue a SORMA for the return of coated oxygenators from the consignee. Sequester the coated oxygenator for return to Gish Biomedical. If the consignees prefer, they can provide a contact name and the number of packages to be picked up and the firm will issue a Federal Express call tag for pick-up at the earliest scheduled time.
Quantity in commerce: 2,306
Distribution: Nationwide (CA, FL, IL, IN, MA, MI, MS, NH, NJ, NY, OH, PA, WI, VA), Canada, and Mexico.
Product codes and lots: 313417, 324404, 241506, 192513, 206510, 241506, 255514, 283507, 40501, 88508, 199547, 208500, 213508, 213508A, 231517, 290542, 007515, 328426, 074507, 122554, 174519, 262552, 323419, 007515, 338420, 035504, 047500, 047501, 047502, 067549, 088507, 122555, 151543, 151542, 215501, 231519, 129535, 250502, 255515, 323419, 336410, 005504, 031514, 087515, 143509, 157511, 199513, 234518, 262511, 313451, 334412, 334412A, 038500, 045550, 053513, 102500, 129525, 160500, 193500, 216501, 252500, 276506, 283512, 241509, 255514, 122554, 047502, 328426, 074507, 125515, 157527, 290519, 199512, 133500, 130500, 241500, 314410, 328426, 213508, 313420, 024509, 004507, 067516, 348414, 101518, 047502, 314409, 323419, 007515, 045557, 059500, 109507, 154510, 046502, 143507, 067518, 101520, 038522, 348418, 038522, 080511, 129527, 206515

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)