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.
FDA Recall Z-1059-2009 · Posted 2009-03-10
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Recalling FirmCook Endoscopy
Recall StatusTerminated
Product CodeKNS
Date Initiated2009-01-21
Date Terminated2010-04-06
Product Quantity10 boxes (100 snares)
Reason for Recall
The snare head is hexagonal but the handle and packaging indicate an oval reorder number.
Firm 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.
Root Cause
Process control
Distribution Pattern
Worldwide Distribution -- USA including states of MI, NY, and WI and country of Australia.
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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