BEUDAMED
    FDA Recall Terminated

    Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500500, Manufactured by Sorin Group USA, Inc. 14401 W. 65th Way Arvada, CO 80004 Indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours.

    Recall: Z-0376-2011 · Initiated October 7, 2010

    Recall

    Recall Number
    Z-0376-2011
    Event Number
    57052
    Firm
    Sorin Group USA, Inc.
    FEI Number
    1718850
    Product Code
    DWF
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    October 7, 2010
    Posted
    November 15, 2010
    Terminated
    December 17, 2010
    Address
    14401 W 65th Way, Arvada, CO, 80004

    Description

    Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500500, Manufactured by Sorin Group USA, Inc. 14401 W. 65th Way Arvada, CO 80004 Indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours.

    Reason

    Defective product packaging may compromise product sterility.

    Action

    Sorin Group sent an "URGENT: FIELD SAFETY NOTICE" letter dated October 7, 2010, to all customers. The letter described the product, problem and action to be taken by customer. The customers were instructed to check all affected inventory to exam for holes. Any damaged products were to be returned to Sorin. If no damage was found, product could be used. The customers were also instructed to contact Sorin Cardiopulmonary Customer Service at 1-800-650-2623 to return product and receive replacement; they were to share this information with all personnel who may use this product; and to complete and return the attached Customer Response Form via the self-addressed prepaid envelope provided or fax to (303) 467-6502 as soon as possible. For further information, contact 1-800-650-2623.

    Distribution

    Nationwide distribution: CA, FL, IL, IN, KS, MD, MO, NE, NJ, NM, TN, TX, and VA.

    Quantity

    79