BEUDAMED
    FDA Enforcement Class I Terminated

    INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantable infusion pump.

    Recall: Z-1522-2022 · Reported August 31, 2022

    Enforcement

    Recall Number
    Z-1522-2022
    Event ID
    90642
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Intera Oncology, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    August 31, 2022
    Initiation Date
    July 10, 2022
    Classification Date
    August 22, 2022
    Termination Date
    September 12, 2023
    Address
    65 William St, Wellesley, MA, 02481-3802, United States

    Description

    INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantable infusion pump.

    Reason

    Higher than expected flow rate.

    Code Info

    UDI-DI: 00850014110147; Catalogue No. AP03000H; Serial No. 16145, 16151, 16154, 16171, 16177, 16179, 16196, 16201, 16204, 16211, 16212, 16219, 16220, 16235, 16244, 16247, 16260, 16270, 16273, 16298, 16304, 16309, 16313, 16319, 16338, 16346, 16354, 16376, 16379, 16389, 16393, 16394, 16395,16402, 16403, 16405, 16408, 16409, 16411, 16425, 16426, 16428, 16433, 16434, 16437, 16450, 16459, 16461, 16464, 16485.

    Distribution

    US distribution to states of: AL, CA, IL, KY, MN, MO, NC, NJ, NY, OH, OR, PA, & TX.

    Quantity

    50 units