Recall Z-0575-06 ยท DTZ Oxygenator, Cardiopulmonary Bypass
Gish Biomedical Inc
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 di
| Date | Mar 1, 2006 (initiated Nov 28, 2005) |
| Status | Terminated |
| Reason | The coated Gish Vision Blood Cardioplegia Systems are associated with an increased incidence of heat exchanger leaks. |
| 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 con |
| Quantity | 1, 216 |
| Distribution | CA, FL, IN, MA, MI, NJ, NY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040355 | VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPORAL HEAT EXCHANGER WITH GBS COATING Gish Biomedical, Inc., Mar 15, 2004 |