BEUDAMED
    FDA Enforcement Class II Terminated

    StoneBreaker Pneumatic Lithotripter, Catalog number: SBL-KIT1; GPN: G52604 UDI:(01)00827002526044

    Recall: Z-1590-2018 · Reported May 9, 2018

    Enforcement

    Recall Number
    Z-1590-2018
    Event ID
    79731
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cook Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 9, 2018
    Initiation Date
    January 31, 2018
    Classification Date
    May 2, 2018
    Termination Date
    April 17, 2020
    Address
    750 N Daniels Way, N/A, Bloomington, IN, 47404-9120, United States

    Description

    StoneBreaker Pneumatic Lithotripter, Catalog number: SBL-KIT1; GPN: G52604 UDI:(01)00827002526044

    Reason

    The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use.

    Code Info

    All Lots

    Distribution

    US Nationwide, OUS countries: AE, AT, AU, BE, BG, BR, CA, CH, CL, CN, CO, CR, CZ, DE, DJ, DK, DO, EC, EE, EG, ES, FI, FJ, FR, GB, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IT, JO, KZ, LB, LT, LV, MA, MO, MX, MY, NI, NL, NO, NZ, PE, PH, PK, PL, PR, PT, QA, RO, RU, SA, SE, SG, SI, SK, SV, TH, TT, TW, UA, UY, XK, ZA

    Quantity

    751