Class 2 Device Recall Stirling Ultracold Portable Shuttle

• Date Initiated by Firm: March 20, 2014
• Date Posted: July 01, 2014
• Recall Status: Terminated on July 01, 2015
• Recall Number: Z-1940-2014
• Recall Event ID: 68333
• Product Classification: Freezer - Product Code JRM
• 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.
• Code Information: Codes: ULT-25-255 & ULT-25-713
• FEI Number: 3001246104
• Recalling Firm/ Manufacturer: Global Cooling Inc; 6000 Poston Rd; Athens OH 45701-9051
• For Additional Information Contact: Customer Service; 740-274-7900
• Manufacturer Reason for Recall: The external power supply input is overheating at the connection to the freezer.
• FDA Determined Cause: Use error
• 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 service@stirlingultracold.com. The Recall Return Response was to be completed and returned.
• Quantity in Commerce: 413 units
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.