BEUDAMED
    FDA Recall Terminated

    Quest Myocardial Protection System (MPS) Arrest/Additive Cassettes

    Recall: Z-1037-03 · Initiated May 23, 2003

    Recall

    Recall Number
    Z-1037-03
    Event Number
    26429
    Firm
    Quest Medical, Inc
    FEI Number
    3001665800
    Product Code
    DWF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 23, 2003
    Posted
    July 22, 2003
    Terminated
    February 18, 2004
    Address
    One Allentown Pkwy, Allen, TX, 75002

    Description

    Quest Myocardial Protection System (MPS) Arrest/Additive Cassettes

    Reason

    Cassettes leak causing a delay of administration of cardioplegia solutions to the heart during open heart surgery.

    Action

    The firm sent letters via fax to consignees on 5/23/2003, 5/28/2003, and 5/29/2003.

    Distribution

    CA, PA, FL, ME, TX, MA, OH, ON, NM, WA, MO, GA, SC, MS, IL, LA, NC, NJ, MA, AK, TN, MT, WI, IN, WV, NE, Japan, Canada

    Quantity

    2158 devices