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ABL800 Flex System-CREA Electrode and Membrane (2014-10-29)
- Starting date:
- October 29, 2014
- Posting date:
- November 26, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-42579
Recalled Products
ABL800 Flex System-CREA Electrode and Membrane
Reason
Radiometer recently became aware that negative drift on QC during in-use lifetime of CREA membranes can be observed.
Affected products
ABL800 Flex System-CREA Electrode and Membrane
Lot or serial number
All lots numbers.
Model or catalog number
942-073
Companies
- Manufacturer
-
Radiometer Medical APS
Akandevej 21
Bronshoj
2700
DENMARK