BEUDAMED
    FDA Enforcement Class II Terminated

    Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 10L GP Bath Model Number: FSGPD10

    Recall: Z-1866-2019 · Reported July 3, 2019

    Enforcement

    Recall Number
    Z-1866-2019
    Event ID
    82903
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Thermo Fisher Scientific (Asheville) LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    July 3, 2019
    Initiation Date
    April 2, 2019
    Classification Date
    June 21, 2019
    Termination Date
    July 23, 2020
    Address
    401 Mill Creek Rd, N/A, Marietta, OH, 45750-4304, United States

    Description

    Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 10L GP Bath Model Number: FSGPD10

    Reason

    Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction and raise the temperature of the fluid in the reservoir above the temperature set point selected by the user.

    Code Info

    Serial Numbers: 300247769 300247772 300247773 300247774 30024777S

    Distribution

    CA, GA, KY, PA Foreign: Canada, China, Germany, Japan, New Zealand, Australia

    Quantity

    5 units