BEUDAMED
    FDA Enforcement Class III Terminated

    Ecolab, Microtek Rolled Probe Cover PC0907NB, Rx Only.

    Recall: Z-0753-2017 · Reported December 21, 2016

    Enforcement

    Recall Number
    Z-0753-2017
    Event ID
    75826
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ecolab Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 21, 2016
    Initiation Date
    November 30, 2016
    Classification Date
    December 14, 2016
    Termination Date
    August 21, 2019
    Address
    370 Wabasha St N, Saint Paul, MN, 55102-1323, United States

    Description

    Ecolab, Microtek Rolled Probe Cover PC0907NB, Rx Only.

    Reason

    The reason for the recall is that the inner carton box of the Rolled Probe Cover PC0907NB has the incorrect expiration date (2015-10-01) on the label while the individual pouch labels and outer shipper have the correct expiration date (2018-10-01). The manufacturing date was inadvertently used as the expiration date on the inner carton box labels.

    Code Info

    15302

    Distribution

    US Distribution to the states of : CA, FL, MI, NJ, TX, UT and VA..

    Quantity

    40 cases (144 eaches per box)