BEUDAMED
    FDA Enforcement Class II Terminated

    Nimbus Administration Set, REF HS-004, UDI # 00817170020031 Product Usage: Administer fluids/medication from a container to a patient through a needle or a catheter.

    Recall: Z-2055-2019 · Reported July 31, 2019

    Enforcement

    Recall Number
    Z-2055-2019
    Event ID
    82997
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    InfuTronix LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 31, 2019
    Initiation Date
    May 28, 2019
    Classification Date
    July 23, 2019
    Termination Date
    June 22, 2020
    Address
    177 Pine St, N/A, Natick, MA, 01760-1331, United States

    Description

    Nimbus Administration Set, REF HS-004, UDI # 00817170020031 Product Usage: Administer fluids/medication from a container to a patient through a needle or a catheter.

    Reason

    Potential for tube leakage

    Code Info

    1) Lot # 1805002, Exp Date 06/10/2021, 2) Lot # 1712005, Exp Date 12/19/2020, 3) Lot # 1710012, Exp Date 10/22/2020, 4) Lot # 1901003, Exp Date 01/07/2022

    Distribution

    US distribution in the state of MA

    Quantity

    10,800 units