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U.S. Department of Health and Human Services

Class 3 Device Recall AcuSnare

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 Class 3 Device Recall AcuSnaresee related information
Date Initiated by FirmApril 21, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on June 10, 2004
Recall NumberZ-0906-04
Recall Event ID 28903
510(K)NumberK851958 
Product Classification Snare, Flexible - Product Code FDI
ProductAcuSnare 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.
Code Information Reorder (Catalog) number: ASM-1, Lot#W1834120 and Reorder (Catalog) number: SASM-1, Lot#W1834310 
Recalling Firm/
Manufacturer		 Wilson-Cook Medical Inc
5951 Grassy Creek Blvd
Winston Salem NC 27105-1206
For Additional Information ContactJessica Hughes
336-744-0157
Manufacturer 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.
FDA Determined
Cause 2		Other
ActionConsignees were notified by visit by sales representatives with follow up letter on 4/21/2004.
Quantity in Commerce5 boxes/10 pouches per box
DistributionMA, NY, OK
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = FDI
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