BEUDAMED
    FDA Enforcement Class III Terminated

    ECOLAB MICROTEK Rolled Probe Cover, 2.0 cm x 20 cm (.8 in x 8 in), Ref PC0905, packaged 1 probe cover/pouch, 25 pouches/carton, 2 cartons/shipping case, Sterile, RX. To be used as a physical barrier for protection against the effects of environmental exposure (e.g. body fluids, gels) and/or to maintain the required hygienic level of various diagnostic or surgical procedures which utilize a transducer (probe).

    Recall: Z-2332-2018 · Reported July 11, 2018

    Enforcement

    Recall Number
    Z-2332-2018
    Event ID
    80160
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    ECOLAB INC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 11, 2018
    Initiation Date
    November 22, 2017
    Classification Date
    June 29, 2018
    Termination Date
    July 22, 2020
    Address
    1 Ecolab Pl, Saint Paul, MN, 55102-2739, United States

    Description

    ECOLAB MICROTEK Rolled Probe Cover, 2.0 cm x 20 cm (.8 in x 8 in), Ref PC0905, packaged 1 probe cover/pouch, 25 pouches/carton, 2 cartons/shipping case, Sterile, RX. To be used as a physical barrier for protection against the effects of environmental exposure (e.g. body fluids, gels) and/or to maintain the required hygienic level of various diagnostic or surgical procedures which utilize a transducer (probe).

    Reason

    The incorrect IFU was shipped with the product.

    Code Info

    Lot numbers D151871, D151961, D161861, D162001, and D162911

    Distribution

    US Distribution to the states of : CA, IL, LA, SC, TX, and WI. There was no foreign/government/military distribution.

    Quantity

    65 cases