BEUDAMED
    FDA Enforcement Class II Terminated

    Model 5001102 MPS Delivery Set w/ arrest agent and additive cassettes, heat exchanger &10 ft. delivery tubing; Model 5001102-AS MPS Delivery Set with 6 ft. delivery tubing; Model 7001102 MPS Low Volume Delivery Set for use with cardiopulmonary bypass equipment.

    Recall: Z-0361-2016 · Reported December 9, 2015

    Enforcement

    Recall Number
    Z-0361-2016
    Event ID
    72524
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Quest Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Press Release
    Report Date
    December 9, 2015
    Initiation Date
    October 28, 2015
    Classification Date
    December 2, 2015
    Termination Date
    November 17, 2016
    Address
    1 Allentown Pkwy, Allen, TX, 75002-4206, United States

    Description

    Model 5001102 MPS Delivery Set w/ arrest agent and additive cassettes, heat exchanger &10 ft. delivery tubing; Model 5001102-AS MPS Delivery Set with 6 ft. delivery tubing; Model 7001102 MPS Low Volume Delivery Set for use with cardiopulmonary bypass equipment.

    Reason

    The products have been found to intermittently exhibit a seal failure during use.

    Code Info

    0491795E04, 0492175E04, 0492185E06, 0492195E06, 0492615E06, 0492625E08, 0492635E08, 0489905Y04, 0490245Y06, 0493075U02, 0493085U02, 0493435U04, 0493675U04, 0493685U07, 494465U07, 0494475U09, 0494855G01, 0495215U11, 0495225U11, 0495505G02, 495515G02, 0496535G08, 0496875G08, 496885G08, 0497245S02, 0495205U11, 497255S04, 0497655S04, 0498535S06, 0498545S06, 0492205E03, 0493695U04, 0494485U07, 0495525G02, 0497265S02, 0495965G04, 0492765E07

    Distribution

    Distributed US (nationwide) and the countries of Canada, Japan, Saudi Arabia, Kuwait, South Africa, Switzerland, France, and Italy.

    Quantity

    18,761 units