BEUDAMED
    FDA Recall Terminated

    Presource(R) Kits (custom surgical/procedural kits): The standard and custom kits are packed with all of the specific disposable class I, II, and II implantable, life-supporting, or life-sustaining devices required by customers for common surgical and other medical procedures

    Recall: Z-3107-2017 · Initiated August 1, 2017

    Recall

    Recall Number
    Z-3107-2017
    Event Number
    77895
    Firm
    Cardinal Health 200, LLC
    FEI Number
    3001236905
    Product Code
    LRO
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    August 1, 2017
    Posted
    August 14, 2017
    Terminated
    June 18, 2019
    Address
    1500 S Waukegan Rd, Waukegan, IL, 60085-6728

    Description

    Presource(R) Kits (custom surgical/procedural kits): The standard and custom kits are packed with all of the specific disposable class I, II, and II implantable, life-supporting, or life-sustaining devices required by customers for common surgical and other medical procedures

    Reason

    The firm manufactured and distributed Presource(R) kits which contained BD SafetyGlide" 22GA 1 inch Needles. BD subsequently recalled these needles because, " Loose polypropylene particulate in the fluid path could be expelled out of the needle during injection.

    Action

    BD sent an Urgent Medical Device Recall letter dated June 12, 2017, to all affected customers. The firm requested the consignee cease use and segregate the products, complete and return the response form. Distributors were requested to notify their customers of the action. Customers with questions were instructed to call 201-847-4267. For questions regarding this recall call 800-292-9332.

    Distribution

    Worldwide Distribution - US (Nationwide) and Internationally to Canada

    Quantity

    184,102 kits