BEUDAMED
    FDA Recall Terminated

    Tri-State Hospital Supply Corp., Centurion Healthcare Products Premie Packs, 50, sterile, Tri-State Hospital Supply Corp., Howell, MI; code no. LM110. Aspiration tray containing Portex uncuffed pediatric sized tracheal tubes.

    Recall: Z-0105-2010 · Initiated September 22, 2009

    Recall

    Recall Number
    Z-0105-2010
    Event Number
    53550
    Firm
    Centurion Medical Products
    FEI Number
    1824619
    Product Code
    BTR
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    September 22, 2009
    Posted
    November 12, 2009
    Terminated
    August 3, 2010
    Address
    301 Catrell Dr, Howell, MI, 48843-1703

    Description

    Tri-State Hospital Supply Corp., Centurion Healthcare Products Premie Packs, 50, sterile, Tri-State Hospital Supply Corp., Howell, MI; code no. LM110. Aspiration tray containing Portex uncuffed pediatric sized tracheal tubes.

    Reason

    The pediatric tracheal tubes used in these kits were manufactured with an internal diameter smaller than indicated in the label, which could result in an inability to remove secretions and cause partial or complete obstruction of the airway.

    Action

    The firm's sales representative was notified of the recall on September 22, 2009 via email and the sole customer was notified by letter dated September 23, 2009. All product was removed from the customer account on September 28, 2009 and returned to the recalling firm.

    Distribution

    Illinois.

    Quantity

    650