BEUDAMED
    FDA Recall Terminated

    TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 5 configuration) Universal Product Number (UPN): M00561411. Distributed by: Boston Scientific. Manufactured by: Horizons International Corp. Intended to be used in flexible endoscopes as a retrieval device for foreign body objects, such as polyps and food boluses.

    Recall: Z-0720-2014 · Initiated November 20, 2013

    Recall

    Recall Number
    Z-0720-2014
    Event Number
    66907
    Firm
    Boston Scientific Corporation
    FEI Number
    3005099803
    Product Code
    FGX
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    November 20, 2013
    Posted
    January 11, 2014
    Terminated
    February 24, 2015
    Address
    100 Boston Scientific Way, Marlborough, MA, 01752-1234

    Description

    TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 5 configuration) Universal Product Number (UPN): M00561411. Distributed by: Boston Scientific. Manufactured by: Horizons International Corp. Intended to be used in flexible endoscopes as a retrieval device for foreign body objects, such as polyps and food boluses.

    Reason

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

    Action

    Boston Scientific issued Customer Notification letters to US accounts via Federal Express Priority mail on November 20, 2013. The notification instructs the account to check their inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests the completion of a Reply Verification Tracking Form.

    Distribution

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

    Quantity

    425 eaches