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.
- Company
- Wilson-Cook Medical Inc
- Recall Initiated
- April 21, 2004
- Posted
- July 20, 2004
- Terminated
- June 10, 2004
- Recall Number
- Z-0906-04
- Quantity
- 5 boxes/10 pouches per box
- Firm Location
- Winston Salem, NC
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.
Distribution
MA, NY, OK
Lot / Code Info
Reorder (Catalog) number: ASM-1, Lot#W1834120 and Reorder (Catalog) number: SASM-1, Lot#W1834310
Root Cause
Other
Action Taken
Consignees were notified by visit by sales representatives with follow up letter on 4/21/2004.
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