BEUDAMED
    FDA Enforcement Class II Terminated

    Stirling Ultracold Portable Shuttle, ULT-25. Storage for cold-chain management, short-term or long-term ultra-low and storage and transport of biological specimens.

    Recall: Z-1940-2014 · Reported July 9, 2014

    Enforcement

    Recall Number
    Z-1940-2014
    Event ID
    68333
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Global Cooling Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 9, 2014
    Initiation Date
    March 20, 2014
    Classification Date
    June 30, 2014
    Termination Date
    July 1, 2015
    Address
    6000 Poston Rd, Athens, OH, 45701-9051, United States

    Description

    Stirling Ultracold Portable Shuttle, ULT-25. Storage for cold-chain management, short-term or long-term ultra-low and storage and transport of biological specimens.

    Reason

    The external power supply input is overheating at the connection to the freezer.

    Code Info

    Codes: ULT-25-255 & ULT-25-713

    Distribution

    Worldwide Distribution -- USA, including the states of AK, AR, AZ, CA, CO, CT, FL, GA, GU, HI, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, and WA; and, the countries of Australia, Brazil, Canada, China, India, Indonesia, Japan, Korea, Kuwait, Mexico, Netherlands, Pakistan, Singapore, Switzerland, Taiwan, Thailand, United Arab Emirates, and United Kingdom.

    Quantity

    413 units