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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