QURA S.R.L. recalls Spectrum Medical Quantum Standard heat exchanger
- Recall date
- March 22, 2021
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2277-2021
- FDA classification
- Class II
- Brand / firm
- QURA S.R.L.
- Sold / distributed
- US Nationwide distribution in the state of South Carolina.
Why it was recalled
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Spectrum Medical Quantum Standard heat exchanger
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