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Device Recall Fresenius GranuFlo (powder) Acid Concentrate
Model / Serial
All lots
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution and the country of Guam.
Product Description
Fresenius GranuFlo (powder) Acid Concentrate || Product Codes: || OFD1201-3B, OFD1251-3B, OFD2123-3B, OFD2201-3B, OFD2220-3B, OFD2223-3B,OFD2225-3B, OFD2231-3B, OFD2251-3B, OFD2301-3B, OFD2323-3B, OFD2325-3B, OFD3201-3B, OFD3231-3B, OFD3251-3B, OFD3301-3B. || For the treatment of acute and chronic renal failure during hemodialysis procedure.
Manufacturer
Fresenius Medical Care Holdings, Inc.
1 Event
Recall of Device Recall Fresenius GranuFlo (powder) Acid Concentrate
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Manufacturer
Fresenius Medical Care Holdings, Inc.
Manufacturer Address
Fresenius Medical Care Holdings, Inc., 920 Winter St, Waltham MA 02451-1521
Manufacturer Parent Company (2017)
Fresenius SE & Co KGaA
Source
USFDA
Language
English
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