Health product recall

5008 Cordiax HD-PAED option (2018-06-26)

Starting date:
June 26, 2018
Posting date:
July 13, 2018
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-67224

Affected products

5008 Cordiax HD-PAED option

Reason

In the unlikely event of a leakage in the hydraulic system, balancing errors of up to 125 ml/h are possible. For patients < 17 kg body weight this could potentially lead to circulatory dysregulation with potential overhydration or underhydration and subsequent impact on cardiovascular stability.

Affected products

5008 Cordiax HD-PAED option

Lot or serial number

All lots.

Model or catalog number

M20 101 1

Companies
Manufacturer
Fresenius Medical Care AG & Co. KGAA
ELSE-KRONER-STRASSE 1
BAD HOMBURG
61352
GERMANY