FDA Device

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.

Hazard

The snares inside the box labeled SASM-1 may actually be ASM-1 devices. The individual pouches may be correctly labeled ASM.

What You Should Do

Remedy

Consignees were notified by visit by sales representatives with follow up letter on 4/21/2004.

Products

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 denote
Brand
Wilson-Cook Medical Inc
UPC
Reorder (Catalog) number: ASM-1, Lot#W1834120 and Reorder (Catalog) number: SASM-1, Lot#W1834310

Units Affected

5 boxes/10 pouches per box