Recall Z-0906-04 ยท FDI Snare, Flexible
Wilson-Cook Medical Inc
AcuSnare Polypectomy Device, Cook Wilson-Cook Medical GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105. The SASM device prefix denotes Soft AcuSnare Mini. The ASM device prefix denotes Acu Snare Mini. Due to the nitinol core wire, the difference between these two products is stiffness of the snare head wire.
| Date | Jul 20, 2004 (initiated Apr 21, 2004) |
| Status | Terminated |
| Reason | The snares inside the box labeled SASM-1 may actually be ASM-1 devices. The individual pouches may be correctly labeled ASM. |
| Root cause | Other |
| Action | Consignees were notified by visit by sales representatives with follow up letter on 4/21/2004. |
| Quantity | 5 boxes/10 pouches per box |
| Distribution | MA, NY, OK |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K851958 | ROTATABLE POLYPECTOMY SNARE POS-1 Wilson-Cook Medical, Inc., Jul 25, 1985 |