BEUDAMED
    FDA Recall Terminated

    Boston Scientific Mach 1 peripheral Guide Catheter 8F, RDC Renal double Curve, .091 in (internal dia), Shaft lenght 55cm, Catalog Number: 19-866, UPN M001198660, Sterile EO, Availmed S.A. de C.V. (Mexico), Boston Scientific Corp., Maple Grove, MN 55311

    Recall: Z-1305-2008 · Initiated February 7, 2008

    Recall

    Recall Number
    Z-1305-2008
    Event Number
    46785
    Firm
    Boston Scientific Corporation One Boston
    FEI Number
    3001451463
    Product Code
    DQY
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    February 7, 2008
    Posted
    May 7, 2008
    Terminated
    November 3, 2008
    Address
    Scientific Place Natick, MA, 01760

    Description

    Boston Scientific Mach 1 peripheral Guide Catheter 8F, RDC Renal double Curve, .091 in (internal dia), Shaft lenght 55cm, Catalog Number: 19-866, UPN M001198660, Sterile EO, Availmed S.A. de C.V. (Mexico), Boston Scientific Corp., Maple Grove, MN 55311

    Reason

    Mislabeled: Seven lots/ batches of Boston Scientific Mach 1 Guide Catheter may be mislabeled with the incorrect device length.

    Action

    Consignees were sent a Boston Scientific Urgent Voluntary Medical Device Recall letter on 2/7/08. The letter included the customer steps for recall, a complete listing of all product batches being recalled, the Reply Verification Tracking Form(s) and a return shipping label.

    Distribution

    Worldwide Distribution including USA states of PA, AZ, NY, KY, CA, WV, OH, WA, MI, TN, IN, IL, NJ, KY, FL, AR, FL, NC, CO, TX, WV, WI, OR, AL, MN and ND and countries of BE, FR, GB, DE, IE, IT, JP, AU, SOUTH KOREA, NZ, TR, TW and ZA.

    Quantity

    4