Spectrum Medical Ltd. recalls Quantum Pump Console
- Recall date
- May 29, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2238-2019
- FDA classification
- Class I
- Brand / firm
- Spectrum Medical Ltd.
- Sold / distributed
- US distribution to NY, OH, VA, WA. International distribution to the Netherlands.
Why it was recalled
Potential for Quantum Pump Console, part of the Quantum Perfusion Systems, to unexpectedly shut down while in use.
Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.
What was recalled
Quantum Pump Console
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