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Fresenius 2008K and 2008T Hemodialysis System (2014-05-07)
- Starting date:
- May 7, 2014
- Posting date:
- September 3, 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-41251
Recalled Products
A) Fresenius 2008K Dialysate System
B) Fresenius 2008K2 Dialysate System
C) Fresenius 2008K Home
D) Fresenius 2008T Hemodialysis System
Reason
Interruption in central water delivery system resulted in a loss of water pressure causing negative pressure in water system compared to hemodialysis machine. This allowed disinfectant from machines to contaminate the central water delivery system and storage tank.
Affected products
A) Fresenius 2008K Dialysate System
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 System
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 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 Hemodialysis System
Lot or serial number
All lots.
Model or catalog number
190573
190713
190766
190908
R190713
R190766
Companies
- Manufacturer
-
Fresenius USA Inc.
4040 Nelson Avenue
Concord
94520
California
UNITED STATES