Z-2277-2021 Class II Terminated
FDA device recall Z-2277-2021 was initiated by QURA S.R.L. on March 22, 2021 and is designated Class II. 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. The recall status is terminated (terminated April 22, 2024). Affected quantity: 1088 units.
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