Recall Z-2277-2021— QURA S.R.L.
Class II · Terminated
Class II FDA medical device recall by QURA S.R.L., initiated 2021-03-22, terminated 2024-04-22. FDA's recall record names no specific 510(k) clearance for this event. Product: Spectrum Medical Quantum Standard heat exchanger. 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..
- Recalling firm
- QURA S.R.L.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-03-22
- Terminated
- 2024-04-22
- Firm location
- Mirandola, N/A, Italy
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.