BEUDAMED
    FDA Enforcement Class II Terminated

    Unolok Blunt Fill Needle 18G x 1.5" Red, Sterile, Single use, Non-injectable needle, Single use, non-injection needle

    Recall: Z-0444-2016 · Reported December 23, 2015

    Enforcement

    Recall Number
    Z-0444-2016
    Event ID
    72616
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Myco Medical Supplies Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 23, 2015
    Initiation Date
    November 6, 2015
    Classification Date
    December 17, 2015
    Termination Date
    May 3, 2017
    Address
    158 Towerview Ct, N/A, Cary, NC, 27513-3595, United States

    Description

    Unolok Blunt Fill Needle 18G x 1.5" Red, Sterile, Single use, Non-injectable needle, Single use, non-injection needle

    Reason

    Particulates: Complaints of rubber coring from the closure of injection vials.

    Code Info

    Item #02463, Lot numbers: 19351R, 16561M, 17531D, 22541D, 22551D, 25551D and 25551M.

    Distribution

    Nationwide Distribution including AZ, CA, CO, FL, GA, IL, IN, KY, LA, MA, MI, NJ, NY, NV, OK, PA, TX and UT.

    Quantity

    2,401,419 units (100ea/bx, 12bx/cs, 1200ea/cs)