BEUDAMED
    FDA Recall Terminated

    ESPRIT VENTILATOR, Model V1000

    Recall: Z-0951-03 · Initiated June 8, 2001

    Recall

    Recall Number
    Z-0951-03
    Event Number
    26432
    Firm
    Respironics California Inc
    FEI Number
    2518422
    Product Code
    CPK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 8, 2001
    Posted
    July 1, 2003
    Terminated
    May 11, 2004
    Address
    2271 Cosmos Ct, Carlsbad, CA, 92009

    Description

    ESPRIT VENTILATOR, Model V1000

    Reason

    Material hardness on original design check valve may cause premature failure.

    Action

    Firm plans to replace all of the check valves in the field. Recall was communicated by issuance of a Field Communication 2001-25 dated 8 June 2001.

    Distribution

    Throughout the US and to Vietnam,Turkey, Thailand, Spain, Singapore, Puerto Rico, Philipines, Peru, Panama, Pakistan, Mexico, Malaysia, Korea, Japan, Italy, Indonesia, Egypt, Columbia, China, Canada, Brazil, Argentina.

    Quantity

    749