AcuSnare Polypectomy Device, Cook Wilson-Cook Medical GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105.
FDA device recall Z-0906-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Wilson-Cook Medical Inc
- Reason for recall
- The snares inside the box labeled SASM-1 may actually be ASM-1 devices. The individual pouches may be correctly labeled ASM.
- Action taken
- Consignees were notified by visit by sales representatives with follow up letter on 4/21/2004.
- Root cause
- Other
- Status
- Terminated
- Product code
- FDI
- Quantity affected
- 5 boxes/10 pouches per box
- Distribution
- MA, NY, OK
- Date initiated
- 2004-04-21
- Date posted
- 2004-07-20
- Date terminated
- 2004-06-10
- Location
- Winston Salem, NC
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ROTATABLE POLYPECTOMY SNARE POS-1 (K851958) | Wilson-Cook Medical, Inc. | 1985-07-25 |