BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-2364-2015 · Initiated July 9, 2015

    Recall

    Recall Number
    Z-2364-2015
    Event Number
    71674
    Firm
    Cadence Inc.
    FEI Number
    1213649
    Product Code
    GAA
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 9, 2015
    Posted
    August 10, 2015
    Terminated
    July 29, 2016
    Address
    2080 Plainfield Pike, Cranston, RI, 02921-2012

    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.

    Action

    Cadence issued the recall letter, specific to the customer dated 7/9/15 via registered mail on July 17, 2015. Accounts are requested to Recalled products must not be used. 2. Locate and quarantine all affected products. 3. Contact Cadence Science, Inc. using the Response Form provided. 4. If this information is received by a dealer, wholesaler, or distributor/reseller that distributed any of these products to other facilities, then notify their customers of this action so that those customers can locate and remove all affected products. Any questions contact: Phone: 401-942-1031

    Distribution

    Nationwide Foreign Canada, Denmark. Italy

    Quantity

    766 units