Recall Z-1393-05 ยท DTZ Oxygenator, Cardiopulmonary Bypass
Boston Scientific Corp
''NAMIC Custom Angiographic Kit'' sold under the following labels: (1) Medical University of South Carolina. Pouch Catalog # 60131481; (2) Covenant Medical Center, Pouch Catalog #60131603; (3) St. Joseph Hospital, Pouch Catalog #60101041; (4) Spectrum Health, Pouch Catalog #61020031 (5) Rush Foundation Hospital, Kit #65185472 ****** Responsible firm on product labels: Boston Scientific/SCIM
| Date | Aug 24, 2005 (initiated May 5, 2004) |
| Status | Terminated |
| Reason | Molded handles used in Angiographic Manifolds may be occluded. |
| Root cause | Other |
| Action | Letters dated 5/4/2004 to Risk Managers with instructions to return product. |
| Quantity | 1115 kits |
| Distribution | The kits were custom made and sold to consignees in IL, KY, MI, SC, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K782095 | STOPCOCKS, MANIFOLDS Namic, Jan 23, 1979 |