Recall Z-0064-04 ยท DXT Injector And Syringe, Angiographic
Acist Medical Systems
ACIST Automated Manifold (Transducer) Kit, Model BT2000, SKU #014613 (used with ACIST Contrast Management Systems (CMS2000) and E2000 Voyager Units)
| Date | Oct 24, 2003 (initiated Oct 2, 2003) |
| Status | Terminated |
| Reason | Some of the automated manifold's 2.5 inch high-pressure lines for radiopaque contrast media, used in angiographic procedures, have separated where they are bonded to the manifold body of the device allowing contrast media to leak. |
| Root cause | Other |
| Action | The consignees were sent letters dated 10/2/03 which requested that the product be returned. |
| Quantity | 7120 kits |
| Distribution | Nationwide in the United States. |
| FDA record | Open on fda.gov |