Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1940-2014Class II

Stirling Ultracold Portable Shuttle, ULT-25. Storage for cold-chain management, short-term or long-term...

Global Cooling Inc / initiated 2014-03-20 / Terminated

Global Cooling Inc began a recall of Stirling Ultracold Portable Shuttle, ULT-25. Storage for cold-chain management, short-term or long-term ultra-low and storage and transport of biological... on . FDA classified it as Class II and gives the reason as "The external power supply input is overheating at the connection to the freezer". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1940-2014
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Global Cooling Inc
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.
Product code
JRM Freezer
Reason for recall
The external power supply input is overheating at the connection to the freezer.
FDA root 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 [email protected]. 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.
Product codes and lots
Codes: ULT-25-255 & ULT-25-713

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1940-2014
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1940-2014Class IITerminatedVoluntary: Firm initiated