FDAMarch 22, 2021device
Spectrum Medical Quantum Standard heat exchanger
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Terminated
Brands named
qura s r lqura
Recall history
No related federal recalls on record for this brand yet.
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