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Devices
Fresenius Modified Mixer Motor
Model / Serial
All 132 Gallon Granuflo Dissolution Units and 132 Gallon Dry Acid Dissolution Units with the H218 Motor and Modified H218 Mixer Motors.
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution.
Product Description
Fresenius Modified Mixer Motor (for 132 Gallon Dissolution Units), P/N 160075. || For Use in the Preparation of acid concentrate for hemodialysis.
Manufacturer
Fresenius Medical Care Renal Therapies Group, LLC
1 Event
Recall of Fresenius Modified Mixer Motor
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Manufacturer
Fresenius Medical Care Renal Therapies Group, LLC
Manufacturer Address
Fresenius Medical Care Renal Therapies Group, LLC, 920 Winter St, Waltham MA 02451-1521
Manufacturer Parent Company (2017)
Fresenius SE & Co KGaA
Source
USFDA
Language
English
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