Recall Z-0730-04 ยท DTZ Oxygenator, Cardiopulmonary Bypass
Gish Biomedical Inc
Vision Hollow Fiber Oxygenator with GBS Coating
| Date | Jul 20, 2004 (initiated Mar 4, 2004) |
| Status | Terminated |
| Reason | Customers reported leakage. |
| Root cause | Other |
| Action | Firm issued recall letters to all customers on March 4, 2004 listing lot numbers and quantities shipped to them. Returns were requested. |
| Quantity | 950 |
| Distribution | NY, PA, AR, IN, IL, NH, SC, NJ, MS, MI, WI, CT, CA |
| 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 |