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Fresenius Dialysate Machines (2013-11-13)
- Starting date:
- November 13, 2013
- Posting date:
- February 10, 2014
- 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-37819
Recalled Products
A. Fresenius 2008K Dialysate Machine
B. Fresenius 2008K2 Dialysate Machine
C. Fresenius 2008K Dialysate Machine Home
D. Fresenius 2008T Dialysate Machine
Reason
Saline bags inappropriately filling during the recirculation phase of hemodialysis treatment set up. During set up, fresh dialysate is produced within the machine to eliminate excess air which has been detected.
Affected products
A. Fresenius 2008K Dialysate Machine
Lot or serial number
All lots
Model or catalog number
190303
190305
190336
190371
190373
190452
Companies
- Manufacturer
-
Fresenius USA Inc.
4040 Nelson Avenue
Concord
94520
California
UNITED STATES
B. Fresenius 2008K2 Dialysate Machine
Lot or serial number
All lots
Model or catalog number
190610
190630
190633
Companies
- Manufacturer
-
Fresenius USA Inc.
4040 Nelson Avenue
Concord
94520
California
UNITED STATES
C. Fresenius 2008K Dialysate Machine Home
Lot or serial number
All lots
Model or catalog number
190395
Companies
- Manufacturer
-
Fresenius USA Inc.
4040 Nelson Avenue
Concord
94520
California
UNITED STATES
D. Fresenius 2008T Dialysate Machine
Lot or serial number
All lots
Model or catalog number
190729
Companies
- Manufacturer
-
Fresenius USA Inc.
4040 Nelson Avenue
Concord
94520
California
UNITED STATES