CanadaQuantum PureFlow Standard Heat Exchanger High Flow devices are affected: models HX55V‑S0W (3/8W) and HX55V‑S0 with lot/serial numbers H000950, H000690, H000832, H000629, G002139, H000193 and H000221. They were recalled because blood‑to‑glycol leakage was identified in the heat exchanger, which may cause blood contamination of the heater‑cooler. Contact the manufacturer, Spectrum Medical Srl, for additional information.
What's being recalled
Companies: Spectrum Medical Srl, Via Di Mezzo 23, Mirandola, Modena, Italy, 41037.
How to identify it
Affected products: Quantum PureFlow Standard Heat Exchanger High Flow 3/8W; Lot or serial number: H000950; Model or catalogue number: HX55V-S0W
Affected products: Quantum PureFlow Standard Heat Exchanger High Flow 3/8W; Lot or serial number: H000690; Model or catalogue number: HX55V-S0W
Affected products: Quantum PureFlow Standard Heat Exchanger High Flow 3/8W; Lot or serial number: H000832; Model or catalogue number: HX55V-S0W
Affected products: Quantum PureFlow Standard Heat Exchanger High Flow 3/8W; Lot or serial number: H000629; Model or catalogue number: HX55V-S0W
Affected products: Quantum PureFlow Standard Heat Exchanger High Flow 3/8; Lot or serial number: G002139; Model or catalogue number: HX55V-S0
Affected products: Quantum PureFlow Standard Heat Exchanger High Flow 3/8; Lot or serial number: H000193; Model or catalogue number: HX55V-S0
Affected products: Quantum PureFlow Standard Heat Exchanger High Flow 3/8; Lot or serial number: H000221; Model or catalogue number: HX55V-S0
The hazard
Blood-to-glycol leakage was identified in the heat exchanger during the procedure. Glycol compartment contamination may result in blood contamination of the heater-cooler due to glycol circulation for thermoregulation. Customer communication is considered necessary to inform users of potential heat exchanger leakage and possible blood contamination of the heater-cooler.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)
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