Device product
Spectrum Medical Quantum Standard heat exchanger
Z-2277-2021
Product summary
- Firm
- QURA S.R.L.
- Event
- Event 88267
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1088 units
- Official record key
device-enforcement:Z-2277-2021
Official wording
Reason: 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.
Code information: Batch Numbers: B000129, C000415, C000416, C000417
Distribution pattern: US Nationwide distribution in the state of South Carolina.
Derived failure modes
-
Sterility assurance
may not have been adequately sterilized