Health product recall

Quantum PureFlow Standard Heat Exchanger High Flow

Last updated

Summary

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

Affected 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.

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General and plastic surgery
Companies

Spectrum Medical Srl

Via Di Mezzo 23, Mirandola, Modena, Italy, 41037

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-82586

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