BEUDAMED
    FDA Recall Terminated

    Mikro 12-24 Centrifuge with 2050 Rotor TYP #2070 and TYP 2070-01. Used for the purpose of determining the hematocrit count of a patient sample by way of applying centrifugal force in a manner that separates red blood cells and allows the proportion of red cell mass to plasma to be measured.

    Recall: Z-0612-2010 · Initiated November 21, 2009

    Recall

    Recall Number
    Z-0612-2010
    Event Number
    53941
    Firm
    Hettich Instruments Management I
    FEI Number
    3004578971
    Product Code
    GKG
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 21, 2009
    Posted
    January 21, 2010
    Terminated
    October 25, 2011
    Address
    100 Cummings Ctr, Ste 130g, Beverly, MA, 01915-6127

    Description

    Mikro 12-24 Centrifuge with 2050 Rotor TYP #2070 and TYP 2070-01. Used for the purpose of determining the hematocrit count of a patient sample by way of applying centrifugal force in a manner that separates red blood cells and allows the proportion of red cell mass to plasma to be measured.

    Reason

    Centrifuge Rotor Failure: may crack, break, and explode outside the centrifuge.

    Action

    Hettich Instruments notified Distributors by email on 11/21/09, to the Request For Urgent Action notifications, dated 11/23/2009. There is a description of how to identify a recalled rotor as well as a description of the replacement metal rotor that is to be used in place of the list of centrifuges affected by this recall. Customers are to cease using the setup described and contact their distributor or the firm. The firm will replace the plastic housing with a metal housing. Questions should be directed to 978-232-3957.

    Distribution

    Worldwide Distribution -- USA, including states of CT and IN, and country of Canada.

    Quantity

    46 units total