FDA-Device2021-08-18Class II
Spectrum Medical Quantum Standard heat exchanger
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.
Sold states
US Nationwide distribution in the state of South Carolina.
Affected count
1088 units
Manufactured in
Via Di Mezzo 23, N/A, Mirandola, N/A, Italy
Products
Spectrum Medical Quantum Standard heat exchanger
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2277-2021Don't want to check this manually?
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