Z-0575-06

The GISH Vision Blood Cardioplegia System with GBS coating (a non-leaching heparin coating) (product...

Name: Z-0575-06 The GISH Vision Blood Cardioplegia System with GBS coating (a non-leaching heparin coating) (product...
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 Blood Cardioplegia System with GBS coating (a non-leaching heparin coating) (product desgination VBCXGBS) consists of an extracorporeal heat... on 2005-11-28. The reason FDA records is "The coated Gish Vision Blood Cardioplegia Systems are associated with an increased incidence of heat exchanger leaks". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0575-06
Status: Terminated
Initiated: 2005-11-28
Posted: 2006-03-01
Terminated: 2007-06-21
Recalling firm: Gish Biomedical, Inc.
Product: The GISH Vision Blood Cardioplegia System with GBS coating (a non-leaching heparin coating) (product desgination VBCXGBS) consists of an extracorporeal heat exhanger and fluid administration set. The heat exchanger consists of a one piece, stainless steel bellows-configured heat exchanger as the primary element to effect heat exchange. This element is encased by a polycarbonate housing, which directs the blood through the convolutions, and therefore improves heat exchange, minimizes priming volume, and reduces shunting. All materials of the heat exchanger are biocompatible. The device allows for the monitoring of pressure and allows for trapping and removal of air. Additionally, the device includes an integral bubble trap, gross filter and pressure relief device designed to open in the event of excessive fluid pressure during use. Solutions are delivered to the patient through a roller pump through the table line extension and appropriate cannula.
Product code: DTZ Oxygenator, Cardiopulmonary Bypass
Reason for recall: The coated Gish Vision Blood Cardioplegia Systems are associated with an increased incidence of heat exchanger leaks.
FDA root cause: Other
Action: The firm faxed all initial consignees a letter notifying them of the recall and the affected lots involved. 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. Gish Customer Service, in conjunction with the sales representative and customer pack office, will work with the consignee in an effort to resolve inventory and configuration issues.
Quantity in commerce: 1, 216
Distribution: CA, FL, IN, MA, MI, NJ, NY
Product codes and lots: 315402, 307412, 336406, 010506, 067511, 080507, 171510, 220523, 336410, 005504, 031514, 087515, 143509, 157511, 199513, 234518, 262511, 0535818, 180501, 348420, 053515, 249512, 125515, 157527, 178525, 130500, 241500, 133500, 320408, 234515, 285417, 313418, 334408, 024507, 053510, 117501, 122508, 151509, 210510, 220526, 224519, 328415, 053511, 067515, 157509, 178520, 199510, 266509, 067518, 101520, 220530, 270503, 348400

Product code DTZ

K040355Class IIVision Blood Cardioplegia System and Extracorporal Heat Exchanger with Gbs CoatingGish Biomedical, Inc. / cleared 2004-03-15

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)