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Terminated

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.

FDA Recall Z-0575-06 · Posted 2006-03-01

Recalling FirmGish Biomedical Inc
Recall StatusTerminated
Product CodeDTZ
Date Initiated2005-11-28
Date Terminated2007-06-21
Product Quantity1, 216

Reason for Recall

The coated Gish Vision Blood Cardioplegia Systems are associated with an increased incidence of heat exchanger leaks.

Firm 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.

Root Cause

Other

Distribution Pattern

CA, FL, IN, MA, MI, NJ, NY

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K040355VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPORAL HEAT EXCHANGER WITH GBS COATINGGish Biomedical, Inc. · 2004-03-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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