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Health product recall

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