BEUDAMED
    FDA Enforcement Class II Terminated

    Micro-Mate Tuberculin Glass Syringe, Non-sterile Catalog numbers 5208, 5209

    Recall: Z-2365-2015 · Reported August 19, 2015

    Enforcement

    Recall Number
    Z-2365-2015
    Event ID
    71674
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cadence Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 19, 2015
    Initiation Date
    July 9, 2015
    Classification Date
    August 10, 2015
    Termination Date
    July 29, 2016
    Address
    2080 Plainfield Pike, N/A, Cranston, RI, 02921-2012, United States

    Description

    Micro-Mate Tuberculin Glass Syringe, Non-sterile Catalog numbers 5208, 5209

    Reason

    Graduation marks of the syringe are not centered with the numeric position marks on the syringe barrel.

    Code Info

    Packged Lots: Catalog Number 5208: 79895-01, 80044-02, 82350-01, W006510/1; Catalog Number 5209: 71880-01, 76434-01, 76461-01, 76461-02, 76461-03, 76461-04, 76461-05, 76461-06, 76461-07, 76461-08, 79748-01, 80044-03, W001711/1, W002337/1, W002886/1

    Distribution

    Nationwide Foreign Canada, Denmark. Italy

    Quantity

    1665 units