BEUDAMED
    FDA Enforcement Class II Terminated

    Reinforced Introducer Sets Maquet 8 Fr., Part Number: 068400040310. It is an accessory to be used for percutaneous insertion of MAQUET IntraAortic Balloon Catheters.

    Recall: Z-0934-2020 · Reported February 12, 2020

    Enforcement

    Recall Number
    Z-0934-2020
    Event ID
    84521
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Datascope Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 12, 2020
    Initiation Date
    November 20, 2019
    Classification Date
    February 1, 2020
    Termination Date
    June 15, 2021
    Address
    15 Law Dr, N/A, Fairfield, NJ, 07004-3206, United States

    Description

    Reinforced Introducer Sets Maquet 8 Fr., Part Number: 068400040310. It is an accessory to be used for percutaneous insertion of MAQUET IntraAortic Balloon Catheters.

    Reason

    Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer Sets Maquet 7 Fr., 7.5 Fr. and 8 Fr. IABs.

    Code Info

    Part Number: 068400040310 UDI: 10607567107943 (068400040310) Lot Codes: 3000079612, 3000043101, 3000036631, 3000015016, TTP.

    Distribution

    US: AK AL AZ CA CO CT FL GA IA ID IL IN KS KY LA MD MI MN MO MS NC ND NE NJ NY OH OK PA SC SD TN TX VA WA WI WV OUS: Switzerland, Netherlands, South Africa, Canada, Germany, Austria, Spain, Italy, Poland, Bharain, Malaysia

    Quantity

    523