BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-1059-2009 · Initiated January 21, 2009

    Recall

    Recall Number
    Z-1059-2009
    Event Number
    51176
    Firm
    Cook Endoscopy
    FEI Number
    1037905
    Product Code
    KNS
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    January 21, 2009
    Posted
    March 10, 2009
    Terminated
    April 6, 2010
    Address
    5951 Grassy Creek Blvd, Winston Salem, NC, 27105-1206

    Description

    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.

    Reason

    The snare head is hexagonal but the handle and packaging indicate an oval reorder number.

    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.

    Distribution

    Worldwide Distribution -- USA including states of MI, NY, and WI and country of Australia.

    Quantity

    10 boxes (100 snares)