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| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1940-2014 | Class II | Terminated | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
