Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Stirling Ultracold Portable Shuttle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Stirling Ultracold Portable Shuttle see related information
Date Initiated by Firm March 20, 2014
Date Posted July 01, 2014
Recall Status1 Terminated 3 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
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 2		 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.
-
-