Recall Z-0815-04 ยท DTZ Oxygenator, Cardiopulmonary Bypass
Medtronic Perfusion Systems
Medtronic Trillium Affinity NT Integrated-CVR Membrance Oxygenator and Cardiotomy Venous Reservoir with Trillium Biopassive Surface (on the oxygenator), Model 541T-R
| Date | Jul 20, 2004 (initiated Mar 25, 2004) |
| Status | Terminated |
| Reason | An incorrect date of manufacture and incorrect use-by date were printed on the labels of the pouches used for the product. |
| Root cause | Other |
| Action | A notification letter, sent on March 25, 2004, requested that consignees complete and return an enclosed certificate which gives the consignee the option of keeping the product or returning it to the firm. |
| Quantity | 132 units |
| Distribution | The product was shipped to consignees in Florida, Iowa, Louisiana, Maine, Minnesota and New York in the United States. |
| FDA record | Open on fda.gov |