FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0906-04
- Recalling firm
- Wilson-Cook Medical Inc
- Product
- 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.
- Status
- Terminated
- Initiated
- 2004-04-21
- Posted
- 2004-07-20
- Terminated
- 2004-06-10
- 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
- Lot, serial or model codes
- Reorder (Catalog) number: ASM-1, Lot#W1834120 and Reorder (Catalog) number: SASM-1, Lot#W1834310
- 510(k) numbers
- ["K851958"]
- PMA numbers
- not on file
- Product code
- FDI
- Firm FEI
- 1037905
- Firm city
- Winston Salem
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28