Recall MonitorHealth Products
Quantum PureFlow Standard Heat Exchanger High Flow
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - General and plastic surgery
Product: Quantum PureFlow Standard Heat Exchanger High Flow
Issue: Medical devices - Sterility
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Quantum PureFlow Standard Heat Exchanger High Flow 3/8W | H000950 | HX55V-S0W |
| Quantum PureFlow Standard Heat Exchanger High Flow 3/8W | H000690 | HX55V-S0W |
| Quantum PureFlow Standard Heat Exchanger High Flow 3/8W | H000832 | HX55V-S0W |
| Quantum PureFlow Standard Heat Exchanger High Flow 3/8W | H000629 | HX55V-S0W |
| Quantum PureFlow Standard Heat Exchanger High Flow 3/8 | G002139 | HX55V-S0 |
| Quantum PureFlow Standard Heat Exchanger High Flow 3/8 | H000193 | HX55V-S0 |
| Quantum PureFlow Standard Heat Exchanger High Flow 3/8 | H000221 | HX55V-S0 |
Issue
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.