BEUDAMED
    FDA Enforcement Class III Terminated

    Manual Diff Dropper, Part Number CHB4001, used for preparing blood samples.

    Recall: Z-0287-2020 · Reported November 13, 2019

    Enforcement

    Recall Number
    Z-0287-2020
    Event ID
    83965
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomedical Polymers, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    November 13, 2019
    Initiation Date
    September 18, 2019
    Classification Date
    November 5, 2019
    Termination Date
    September 15, 2020
    Address
    16 Chocksett Rd, N/A, Sterling, MA, 01564-2336, United States

    Description

    Manual Diff Dropper, Part Number CHB4001, used for preparing blood samples.

    Reason

    The metal cannula of the device either broke and the broken piece left in the blood specimen tube, or slid back into the plastic portion of the device instead of piercing the tube.

    Code Info

    UPC: (01) 50885380116009 Lot numbers: 20180709A1C, 20180717A1C

    Distribution

    US nationwide distribution.

    Quantity

    2,052,000