Vision Hollow Fiber Oxygenator
FDA device recall Z-0780-03 · posted 2003-04-22 · Terminated
Recall details
- Recalling firm
- Gish Biomedical Inc
- Reason for recall
- Two reports of leakage.
- Action taken
- The firm sent recall letters by fax on March 31, 2003 requesting that the customer make arrangements to return the product.
- Root cause
- Other
- Status
- Terminated
- Quantity affected
- 1749
- Distribution
- Nationwide, Austria, Canada, Japan, Saudi Arabia
- Date initiated
- 2003-03-31
- Date posted
- 2003-04-22
- Date terminated
- 2004-03-09
- Location
- Rancho Santa Margarita, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GISH RELIANCE OXYGENATOR (MODEL HFO) (K961530) | Gish Biomedical, Inc. | 1996-12-05 |