BEUDAMED
    FDA Recall Terminated

    ARROW OnControl Ported Aspiration System Tray, Sterile, Rx only, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients. The Arrow OnControl Bone Marrow Biopsy System is intended for bone marrow core biopsy of the anterior or posterior iliac crest of adult patients

    Recall: Z-0679-2017 · Initiated November 8, 2016

    Recall

    Recall Number
    Z-0679-2017
    Event Number
    75637
    Firm
    Teleflex Medical
    FEI Number
    3005747797
    Product Code
    KNW
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 8, 2016
    Terminated
    November 20, 2019
    Address
    2917 Weck Dr, Research Triangle Park, NC, 27709-0186

    Description

    ARROW OnControl Ported Aspiration System Tray, Sterile, Rx only, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients. The Arrow OnControl Bone Marrow Biopsy System is intended for bone marrow core biopsy of the anterior or posterior iliac crest of adult patients

    Reason

    Sterility: Due to a potential incomplete seal on the outer sterile package.

    Action

    Teleflex sent an Urgent Medical Device Recall Notification letter dated November 8, 2016, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use and quarantine any affected product, complete the enclosed Recall Acknowledgement Form and fax to 1-855-419-8507, Attn: Customer Service or email to [email protected]. Customers with questions were instructed to call their local sales representative or Customer Service at 1-866-246-6990. For questions regarding this recall call 919-433-4940.

    Distribution

    Worldwide Distribution - US (nationwide) Internationally to Brazil, Canada, Ecuador, Guatemala, Mexico and Peru.