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QURA S.R.L. recalls Spectrum Medical Quantum Standard heat exchanger
Recalled August 18, 2021 · FDA recall Z-2277-2021 · QURA S.R.L
Hazard
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. · FDA Class II
Units
1088 units
Sold at
US Nationwide distribution in the state of South Carolina.
Description
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.
Product
Spectrum Medical Quantum Standard heat exchanger
Manufacturer(s)
QURA S.R.L.
Made in
Italy
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →