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.
FDA Recall Z-0906-04 · Posted 2004-07-20
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Recalling FirmWilson-Cook Medical Inc
Recall StatusTerminated
Product CodeFDI
Date Initiated2004-04-21
Date Terminated2004-06-10
Product Quantity5 boxes/10 pouches per box
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.
Firm Action
Consignees were notified by visit by sales representatives with follow up letter on 4/21/2004.
Root Cause
Other
Distribution Pattern
MA, NY, OK
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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