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Heater Unit HU 35
- Starting date:
- January 3, 2017
- Posting date:
- January 25, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-61944
Reason
The current published instructions for use chapter 6 "Cleaning and Disinfection" for HU 35 Heater Units will be replaced by revised instructions for use - Cleaning, Descaling and Disinfecting Heater Unit HU 35. The latter outlines especially a new weekly routine disinfection as well as a high level disinfection and biofilm reduction - also effective against atypical mycobacteria in the water system.
Affected products
Heater Unit HU 35
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- 70104.9090
Companies
- Manufacturer
-
Maquet Cardiopulmonary GmbH
Kehler Str. 31
Rastatt
76437
GERMANY