Recall Z-0519-06 ยท DTZ Oxygenator, Cardiopulmonary Bypass
Gish Biomedical Inc
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 whic
| Date | Feb 14, 2006 (initiated Nov 28, 2005) |
| Status | Terminated |
| Reason | Gish received four reports of potential leakage. All reports were associated with GBS coating. There was no patient injury reported. |
| 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 retu |
| Quantity | 2,306 |
| Distribution | Nationwide (CA, FL, IL, IN, MA, MI, MS, NH, NJ, NY, OH, PA, WI, VA), Canada, and Mexico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023381 | VISION HOLLOW FIBER OXYGENATOR WITH GUARDIAN COATING Gish Biomedical, Inc., Mar 31, 2003 |