Z-2277-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 18, 2021
- Initiation Date
- March 22, 2021
- Termination Date
- April 22, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1088 units
Product Description
Spectrum Medical Quantum Standard heat exchanger
Reason for Recall
Product labeled as sterile may not have been adequately sterilized. In addition, these devices were imported to the US distributor, but the devices are not 510(k) cleared in the US.
Distribution Pattern
US Nationwide distribution in the state of South Carolina.
Code Information
Batch Numbers: B000129, C000415, C000416, C000417