medical Class II Updated 2021-08-18

QURA S.R.L. recalls Spectrum Medical Quantum Standard heat exchanger

Recalled Product

Spectrum Medical Quantum Standard heat exchanger


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Batch Numbers: B000129, C000415, C000416, C000417
View official government recall

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