Gish Biomedical Inc
Vision Hollow Fiber Oxygenator
| Date | Apr 22, 2003 (initiated Mar 31, 2003) |
| Status | Terminated |
| Reason | Two reports of leakage. |
| Root cause | Other |
| Action | The firm sent recall letters by fax on March 31, 2003 requesting that the customer make arrangements to return the product. |
| Quantity | 1749 |
| Distribution | Nationwide, Austria, Canada, Japan, Saudi Arabia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K961530 | GISH RELIANCE OXYGENATOR (MODEL HFO) Gish Biomedical, Inc., Dec 5, 1996 |