BEUDAMED
    FDA Recall 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 · Initiated March 20, 2014

    Recall

    Recall Number
    Z-1940-2014
    Event Number
    68333
    Firm
    Global Cooling Inc
    FEI Number
    3001246104
    Product Code
    JRM
    Status
    Terminated
    Root Cause
    Use error
    Initiated
    March 20, 2014
    Posted
    July 1, 2014
    Terminated
    July 1, 2015
    Address
    6000 Poston Rd, Athens, OH, 45701-9051

    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.

    Action

    Consignees received an Urgent Medical Device Recall letter, dated March 20, 2014, a Recall Response letter, a User Alert, and a label to attach to the freezer power supply input. The letter identified the reason for the recall and how to recognize that the device may fail. Customers are to discontinue use of the device if there are any signs of a loose connection, corrosion, discoloration, or melting; and take the necessary actions identified, including contacting Global Cooling Customer Service at [email protected]. The Recall Return Response was to be completed and returned.

    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