BEUDAMED
    FDA Enforcement Class II Terminated

    TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 10 configuration) Intended to be used in flexible endoscopes as a retrieval device for foreign body objects, such as polyps and food boluses. Universal Product Number (UPN):M00561422 Distributed by: Boston Scientific, Natick, MA. Manufactured by: Horizons International Corp., Costa Rica.

    Recall: Z-0724-2014 · Reported January 22, 2014

    Enforcement

    Recall Number
    Z-0724-2014
    Event ID
    66907
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Boston Scientific Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 22, 2014
    Initiation Date
    November 20, 2013
    Classification Date
    January 11, 2014
    Termination Date
    February 24, 2015
    Address
    100 Boston Scientific Way, Marlborough, MA, 01752-1234, United States

    Description

    TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 10 configuration) Intended to be used in flexible endoscopes as a retrieval device for foreign body objects, such as polyps and food boluses. Universal Product Number (UPN):M00561422 Distributed by: Boston Scientific, Natick, MA. Manufactured by: Horizons International Corp., Costa Rica.

    Reason

    Sterility of device may be compromised due to lack of pouch seal integrity

    Code Info

    Lot Numbers: H13061102, H13061104, H13062401, H13062402, H13071302, H13082603

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Canada, Austria, Australia, New Zealand, France, Spain, Portugal, Italy, Switzerland, Denmark, and Netherlands.

    Quantity

    3,300 eaches