Reported Aug 18, 2021 · Terminated
Spectrum Medical Quantum Standard heat exchanger
Qura S.r.l.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: QURA S.R.L. · Via Di Mezzo 23 · Mirandola, N/A · N/A
Is this the product you have?
- Spectrum Medical Quantum Standard heat exchanger
- Lot codes and dates
- Batch Numbers
B000129C000415C000416C000417
- Batch Numbers
- Amount recalled
- 1088 units
Where it was sold
- Nationwide
- SC
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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