BEUDAMED
    FDA Recall Terminated

    Terumo Sarns Level Sensor II Pads. Terumo Cardiovascular Systems Corporation. Used to attach level sensors to the sides of the venous reservoir.

    Recall: Z-3176-2011 · Initiated August 12, 2011

    Recall

    Recall Number
    Z-3176-2011
    Event Number
    59455
    Firm
    Terumo Cardiovascular Systems Corporation
    FEI Number
    1828100
    Product Code
    KRI
    Status
    Terminated
    Root Cause
    Incorrect or no expiration date
    Initiated
    August 12, 2011
    Posted
    September 9, 2011
    Terminated
    June 20, 2012
    Address
    6200 Jackson Road, Ann Arbor, MI, 48103-9586

    Description

    Terumo Sarns Level Sensor II Pads. Terumo Cardiovascular Systems Corporation. Used to attach level sensors to the sides of the venous reservoir.

    Reason

    Level Sensor II mounting pads may not stick to the venous reservoir and may detach either at case setup or during a case.

    Action

    Terumo Cardiovascular Systems Corp. sent an "Urgent Medical Device Removal" notice dated August 10, 2011 to all affected customers. The notice instructs customers to discard all remaining level sensor pads that do not have an expiration date on the package, and notify Terumo of the number of affected pads via a response form. Terumo will replace recalled product. For questions on this recall call Terumo Customer Service at (800) 521-2818, 8 am-6 pm EST.

    Distribution

    Worldwide Distribution -- Nationwide Distribution, and the island of Puerto Rico.

    Quantity

    1,531,440 devices