BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1522-2022 · Initiated July 10, 2022

    Recall

    Recall Number
    Z-1522-2022
    Event Number
    90642
    Firm
    Intera Oncology, Inc.
    FEI Number
    3015537318
    Product Code
    LKK
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    July 10, 2022
    Posted
    August 22, 2022
    Terminated
    September 12, 2023
    Address
    65 William St, Wellesley, MA, 02481-3802

    Description

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

    Reason

    Higher than expected flow rate.

    Action

    Customers were notified by a combination of letter, call, and/or email of this recall on July 10, 2022. Customers were informed via notification that Intera 3000 Hepatic Artery Infusion Pumps are being recalled due to complaints reporting higher-than-expected flow rates. Customers are asked to secure affected pumps in inventory to ensure they are not implanted and to contact Intera Oncology at 1-800-660-2660 to arrange return of product. Intera requests physicians continue to monitor the pump flow rate per standard refill procedure, and continue to monitor for liver toxicity to adjust dosing as per standard protocols.

    Distribution

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

    Quantity

    50 units