Spectrum Medical Quantum Standard heat exchanger
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 You Should Do
Remedy
The firm notified their consignee of the problem by email beginning on 02/18/2021. They issued a recall noticed on 03/22/2021 by email.
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Products
Spectrum Medical Quantum Standard heat exchanger
- Brand
- QURA S.R.L. Via Di Mezzo
- UPC
- Batch Numbers: B000129, C000415, C000416, C000417
Units Affected
1088 units