BEUDAMED
    FDA Enforcement Class II Terminated

    Unifine Pentips 5mm x 31G pen needles, packaged in 30 ct pen needles. Product Usage: Sterile, non-toxic, non-pyrogenic, single use pen needles for the subcutaneous injection of drugs from pen injectors.

    Recall: Z-0382-2018 · Reported January 24, 2018

    Enforcement

    Recall Number
    Z-0382-2018
    Event ID
    78483
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Owen Mumford USA, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 24, 2018
    Initiation Date
    November 6, 2017
    Classification Date
    January 17, 2018
    Termination Date
    February 12, 2021
    Address
    1755 W Oak Commons Ct, N/A, Marietta, GA, 30062-2280, United States

    Description

    Unifine Pentips 5mm x 31G pen needles, packaged in 30 ct pen needles. Product Usage: Sterile, non-toxic, non-pyrogenic, single use pen needles for the subcutaneous injection of drugs from pen injectors.

    Reason

    Device may potentially be compromised by water in end user packaging. Exposure to liquid may compromise sterility. This may appear as discoloring or yellowing of the device's protective seal.

    Code Info

    UPC #384701150012: Batch No. AN 1150, Lot No.1705711.T098; Batch No. 1150REC, Lot No. 1705722.T099; Batch No. AN 1150HEB, Lot No. 1705722.T100.

    Distribution

    US Nationwide Distribution in the states of AL, AZ, CA, CO, FL, GA, HI, IA, IL, MA, MI, MN, MO, MS, NC, NH NJ, NY, OH, OK, PA, TN, NX, UT, VA, VT, WA, WV

    Quantity

    708 cartons (21,240 pen needles)