BEUDAMED
    FDA Recall Terminated

    Trach-Eze Closed Suction System Endotracheal Start Kit *** 16F *** REF 220070 *** Catheter Length: 571 mm *** STERILE ***.

    Recall: Z-0496-03 · Initiated November 25, 2002

    Recall

    Recall Number
    Z-0496-03
    Event Number
    25200
    Firm
    Sorenson Medical, Inc.
    FEI Number
    1000117099
    Product Code
    BSY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 25, 2002
    Posted
    January 30, 2003
    Terminated
    July 12, 2004
    Address
    1375 West 8040 South, West Jordan, UT, 84107-2649

    Description

    Trach-Eze Closed Suction System Endotracheal Start Kit *** 16F *** REF 220070 *** Catheter Length: 571 mm *** STERILE ***.

    Reason

    Catheters have 2 unvalidated seal product configurations to produce a new hybrid seal that had not been verified or validated.

    Action

    On 10/25/2002, all consignees were notified by letter.

    Distribution

    Distributors in IL, OH, PA. Foreign distribution to Brazil, Czech Republic, Denmark, Guatemala, Italy.

    Quantity

    2790 units