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U.S. Department of Health and Human Services

Class 3 Device Recall AcuSnareAcuSnare Polypectomy Soft Snare

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  Class 3 Device Recall AcuSnareAcuSnare Polypectomy Soft Snare see related information
Date Initiated by Firm January 21, 2009
Date Posted March 10, 2009
Recall Status1 Terminated 3 on April 06, 2010
Recall Number Z-1059-2009
Recall Event ID 51176
510(K)Number K851958  
Product Classification Endoscopic Electrosurgical Unit - Product Code KNS
Product AcuSnare Polypectomy Soft Snare, Order number SASM-1, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105, packed 5 boxes, 10 units per box.

This device is used with an electrosurgical unit for endoscopic polypectomy.
Code Information Lot number: W23594445 and W2594446, Exp. Date: 10-2011
Recalling Firm/
Manufacturer		 Cook Endoscopy
5951 Grassy Creek Blvd
Winston Salem NC 27105-1206
For Additional Information Contact Sharon Miles
336-744-0157 Ext. 6325
Manufacturer Reason
for Recall		 The snare head is hexagonal but the handle and packaging indicate an oval reorder number.
FDA Determined
Cause 2		 Process control
Action Consignees were notified via USPC, Certified Mail and email on/about 1/21/2009 with an Urgent - Product Recall Notice. The distributor (Cook Australia) was instructed to return quarantined product to Cook Endoscopy. All medical users were instructed to review the attached list and quarantine any affected product remaining at their facility. They were to complete the form at the bottom of the page and send/fax it. Users are to return any affected product to Cook Endoscopy. All devices returned as part of this recall initiative will be dispositioned to scrap and destroyed.
Quantity in Commerce 10 boxes (100 snares)
Distribution Worldwide Distribution -- USA including states of MI, NY, and WI and country of Australia.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = KNS and Original Applicant = WILSON-COOK MEDICAL, INC.
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