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Ultrafilter U9000 (2014-08-08)
- Starting date:
- August 8, 2014
- Posting date:
- September 25, 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-41523
Recalled products
- Ultrafilter U9000
Reason
There is a possibility of external fluid leakage with all lots of Ultrafilter U9000 (model number U9000) as a result of multiple disinfections using a sodium carbonate based solution (clean cart A).
Affected products
A. Ultrafilter U9000
Lot or serial number
All lots
Model or catalog number
- U 9000
Companies
- Manufacturer
-
Gambro Dialysatoren GmbH,
Holger-Crafoord-Strasse 26,
Hechingen
72379
GERMANY