Quantum PureFlow Standard Heat Exchanger High Flow Recall
Areazine synthesizes this Health Canada recall directly from Health Canada's official public data feed. See our methodology for full source attribution and refresh cadence.
Health Canada recalls Quantum PureFlow Standard Heat Exchanger High Flow devices due to identified blood-to-glycol leakage and potential blood contamination.
What this Health Canada recall tells you, and what most readers miss
This notice was issued by Health Canada on September 2, 2026 and geographically references Canada. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - Product & Food Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, health-canada, MedicalDevice.
What Happened
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.
Which Products Are Affected
The following Quantum PureFlow Standard Heat Exchanger High Flow products are affected:
- Quantum PureFlow Standard Heat Exchanger High Flow 3/8W, model HX55V-S0W, lot H000950
- Quantum PureFlow Standard Heat Exchanger High Flow 3/8W, model HX55V-S0W, lot H000690
- Quantum PureFlow Standard Heat Exchanger High Flow 3/8W, model HX55V-S0W, lot H000832
- Quantum PureFlow Standard Heat Exchanger High Flow 3/8W, model HX55V-S0W, lot H000629
- Quantum PureFlow Standard Heat Exchanger High Flow 3/8, model HX55V-S0, lot G002139
- Quantum PureFlow Standard Heat Exchanger High Flow 3/8, model HX55V-S0, lot H000193
- Quantum PureFlow Standard Heat Exchanger High Flow 3/8, model HX55V-S0, lot H000221
Manufactured by Spectrum Medical Srl, Via Di Mezzo 23, Mirandola, Modena, Italy, 41037.
What You Should Do
Customer communication is considered necessary to inform users of potential heat exchanger leakage and possible blood contamination of the heater-cooler.
Why This Matters
Potential blood contamination of the heater-cooler poses a risk of blood contamination during medical procedures.
Source
Original source: Health Canada Official Notice ↗
Related Product & Food Recalls
All Product & Food Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this Health Canada recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,495 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to September 2, 2026.
Frequently Asked Questions
Common questions about this Health Canada recall.