BEUDAMED
    FDA Recall Terminated

    Cobe Optima XP Hollow Fiber Membrane Oxygenator, Sterile, (Custom Heart/Lung Packs), Catalog Numbers: 028901008, 032794001, 067129002, 067149006, 067174002, 067188002, 067212004, 067221009, 067236004, 067260001, 067296002, 067351006, 067354002, 067388004, 067434005, 067442001, 067447010, 067452001, 067458005, 067481003, 06748002, 067523001, 067529002, 067536002, 067539005, 067570003, 067577001, 067594003, 067602001, 067614005, 067625001, 067634005, 067662002, 067668001, 067682001, 067683003, 067686005, 067694002, 067709001, 067710001, 067714001, 067721002, 067722001, 067735002, 078011601, 078011701, 078014002, 078107009, 078149017, 078183015, 078196012, 078249006, 078280017, 078346013, 078351010, 078399009, 078439012, 078522010, 078534012, 078541004, 078549011, 078574008, 078707005, 078766004, 078892004, 078898003, 078909002, 0789337004, 078959005, 078987001, 078988002, 07896006. COBE Cardiovascular, Inc..

    Recall: Z-1425-06 · Initiated June 26, 2006

    Recall

    Recall Number
    Z-1425-06
    Event Number
    35839
    Firm
    Cobe Cardiovascular, Inc
    FEI Number
    1718850
    Product Code
    DTZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 26, 2006
    Posted
    August 24, 2006
    Terminated
    August 8, 2011
    Address
    14401 W 65th Way, Arvada, CO, 80004-3524

    Description

    Cobe Optima XP Hollow Fiber Membrane Oxygenator, Sterile, (Custom Heart/Lung Packs), Catalog Numbers: 028901008, 032794001, 067129002, 067149006, 067174002, 067188002, 067212004, 067221009, 067236004, 067260001, 067296002, 067351006, 067354002, 067388004, 067434005, 067442001, 067447010, 067452001, 067458005, 067481003, 06748002, 067523001, 067529002, 067536002, 067539005, 067570003, 067577001, 067594003, 067602001, 067614005, 067625001, 067634005, 067662002, 067668001, 067682001, 067683003, 067686005, 067694002, 067709001, 067710001, 067714001, 067721002, 067722001, 067735002, 078011601, 078011701, 078014002, 078107009, 078149017, 078183015, 078196012, 078249006, 078280017, 078346013, 078351010, 078399009, 078439012, 078522010, 078534012, 078541004, 078549011, 078574008, 078707005, 078766004, 078892004, 078898003, 078909002, 0789337004, 078959005, 078987001, 078988002, 07896006. COBE Cardiovascular, Inc..

    Reason

    Cooling and rewarming time is extended. Efficiency of the heat exchangers is reduced because many of the folds that are critical to heat exchange on the blood side of the units were blocked with a metalic material, thus decreasing the surface area needed for proper heat transfer.

    Action

    Consignees were notified by letter on 06/26/2006.

    Distribution

    Worldwide distribution --- USA including VA facilities in CO, GA, MO and countries of Australia, Canada, Italy, and Japan

    Quantity

    3438 units (Domestic)