BEUDAMED
    FDA Recall Terminated

    Ablation Galil Technology, IcePearl 2.1 CX 90 Cyroablation Needles, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.

    Recall: Z-2682-2020 · Initiated June 4, 2020

    Recall

    Recall Number
    Z-2682-2020
    Event Number
    85815
    Firm
    Boston Scientific Corporation
    FEI Number
    3005099803
    Product Code
    GEH
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 4, 2020
    Terminated
    September 23, 2024
    Address
    300 Boston Scientific Way, Marlborough, MA, 01752-1291

    Description

    Ablation Galil Technology, IcePearl 2.1 CX 90 Cyroablation Needles, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.

    Reason

    The needle surface deteriorated due to unexpected electrolysis during procedure.

    Action

    Boston Scientific sent a letter dated 06/04/2020 and titled, "Urgent Medical Device Removal - Immediate Action Required" to customers regarding the IceFORCE 2.1 CX and IcePearl 2.1 CX Cryoablation Needles. The firm initiated a removal of specific lots/batches of IceFORCE 2.1 CX and IcePearl 2.1 CX Cryoablation Needles. The letter states that further distribution or use of any remaining product affected by the removal should cease immediately. Customers should verify the product lot/batch number to identify whether any product within their inventory is affected. If they have affected product in their inventory customers should respond and follow the instructions on the verification form. Customers must complete the Reply Verification Tracking Form and returned even if you do not have any of the units from the recalled lot/batch and email or fax your Reply Verification Tracking Form(s) immediately to get a Returned Goods Authorization Number (RGA #) before you return any product. Email: [email protected] or Fax to: Field Action Center 1-866-213-1806. Package/Ship the Recalled Product. Seal the box, and return to: Boston Scientific Corporation, US Distribution Center Boston Scientific Marina Bay Customer Fulfillment Center 500 Commander Shea Blvd. Quincy, Massachusetts 02171 RGA: Replacement product will be provided once affected product has been received by Boston Scientific Distributors should forward the notification to customers. Facilities that have sent products to another hospital within their network, should ensure that the notification is forwarded to them. Customers should contact their local sales representatives; email: [email protected] or can contact Sr. Regulatory Affairs Specialist at 508-683-40 or email: [email protected] regarding any questions associated with the notification. [email protected]

    Distribution

    Nationwide Distribution to states of: AL, AR, AZ, CA, CO, CT, DE, DC, FL, GA, HI, IA, ID, KS, LA, MA, MD, ME, MN, MO, MS, NC, ND, NE, NJ, NM, NY, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI WV, and WY and the country of: Canada.

    Quantity

    205 devices