Heater Unit Hu35
Brand(s)
Last updated
Summary
Product
Heater Unit Hu35
Issue
Medical devices - Device compatibility
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| Heater Unit Hu35 | More than 10 numbers, contact manufacturer. | 70107.2163 70104.9090 |
Issue
Statistical analysis indicates that with increasing operation time of the HU 35, the probability of leakage within its expected service life of 10 years increases due to material degradation of the tank fittings. Tank fittings and the screw cap of the tank outflow point need to be replaced with components in a new, more robust material.
Recall start date: May 16, 2022
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Physical medicine
Companies
Maquet Cardiopulmonary Gmbh
Kehler Strasse 31, Rastatt, Germany, 76437
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-64212
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