BEUDAMED
    FDA Enforcement Class II Terminated

    Perfectum Tuberculin Glass Syringe, Non sterile Catalog numbers 5202, 5205, 5212

    Recall: Z-2364-2015 · Reported August 19, 2015

    Enforcement

    Recall Number
    Z-2364-2015
    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

    Perfectum Tuberculin Glass Syringe, Non sterile Catalog numbers 5202, 5205, 5212

    Reason

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

    Code Info

    Packged Lots: Catalog Number 5202: 79713-04, 80468-05, W003542/1, W006324/1, W006324/2, W006324/3, W006324/4, W006324/5; Catalog Number 5205: 79748-03; Catalog Number 5212: W008136/1, W008686/1, W011240/1, W010905/1, W012135/1, W014053/1, W015838/1, W011240

    Distribution

    Nationwide Foreign Canada, Denmark. Italy

    Quantity

    766 units