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Heater-Cooler Unit HCU 40
- Starting date:
- December 14, 2016
- Posting date:
- January 12, 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-61728
Reason
Maquet Cardiopulmonary developed and validated new and revised cleaning and disinfection procedures for HEATER-COOLER UNIT (HCU) 40 including a routine disinfection protocol and a protocol for highly effective disinfection also effective against atypical mycobacteria in the water system to be implemented on all HCU 40 systems in the field. The implementation of the new procedures for installed HCU 40 units requires an update by authorized Maquet service personnel. Customers will be notified and technicians will be dispatched to perform the updates and distribute new instructions for use (IFUs).
Affected products
Heater-Cooler Unit HCU 40
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
70105.4054 (200-240V)
70105.4917 (110-120V)
Companies
- Manufacturer
-
MAQUET CARDIOPULMONARY GMBH
KEHLER STR. 31, RASTATT, GERMANY, 76437
RASTATT
76437
GERMANY