BEUDAMED
    FDA Recall Terminated

    Medical Device Exchange -APPLIER, MULTICLIP ROTATING; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 3299; EXP (repackager), Covidien (OEM) Clip, implantable

    Recall: Z-2226-2015 · Initiated February 11, 2015

    Recall

    Recall Number
    Z-2226-2015
    Event Number
    71608
    Firm
    EXP Pharmaceutical Services Corp
    FEI Number
    3004376386
    Product Code
    FCP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 11, 2015
    Posted
    July 24, 2015
    Terminated
    December 30, 2015
    Address
    48021Warm Springs Boulevard, Fremont, CA, 94539

    Description

    Medical Device Exchange -APPLIER, MULTICLIP ROTATING; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 3299; EXP (repackager), Covidien (OEM) Clip, implantable

    Reason

    EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.

    Action

    EXP first notified their customers to quarantine EXP devices February 11-17, 2015. Customers were contacted through telephone, e-mail, and written communications. Customers were instructed to recover and quarantine all EXP products from their inventories. EXP believes that they have contacted all customers to whom products were shipped between April 26, 2014, and December 9, 2014. A second letter is scheduled to be sent in July 2015 (date unknown at this time). This letter will advise users of the recall of due to lack of registration with the FDA.

    Distribution

    Distributed in DC and the states of CO, CA, FL, TX, and AR.

    Quantity

    17