BEUDAMED
    FDA Recall Terminated

    NeoPAP Neonatal CPAP/Humidification System (Ventilator, Continuous)

    Recall: Z-0717-06 · Initiated December 27, 2005

    Recall

    Recall Number
    Z-0717-06
    Event Number
    34390
    Firm
    Respironics, Inc.
    FEI Number
    2518422
    Product Code
    CBK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 27, 2005
    Posted
    April 7, 2006
    Terminated
    March 22, 2007
    Address
    1001 Murry Ridge Ln, Murrysville, PA, 15668

    Description

    NeoPAP Neonatal CPAP/Humidification System (Ventilator, Continuous)

    Reason

    Vapotherm humidification cartridges were found to contain microbial (Ralstonia spp.) cultures. This device uses cartridges from the same supplier.

    Action

    Respironics contacted customers via tracked letter informing them to discontinue use of their NeoPAP system. Distributors were contacted via telephone and e-mail instructing them to contact their customers and instruct them to discontinue use of the NeoPAP system. The recalling firm issued a Customer Advisory Notice (CAN) dated 1/5/06 to all customers.

    Distribution

    The product was shipped to medical facilities in GA, IA, MA, MN, NJ, OK, PA, TX, and WI. The product was also shipped to Sweden, South Africia, Egypt, Greece, and Saudi Arbia.

    Quantity

    83 effected units were identified