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Recall Observatory FDA recall evidence

Device product

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.

Z-1940-2014

March 20, 2014

Class II

Product summary

Firm
Global Cooling Inc
Event
Event 68333
Status
Terminated
Classification
Class II
Quantity
413 units
Official record key
device-enforcement:Z-1940-2014

Official wording

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

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

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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