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Device Recall Fresenius Naturalyte Liquid Acid Concentrate
Model / Serial
Lot Number: 15STAC072 Exp Date: 2017-12-31
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
US Distribution to states of: KS, LA, MS, OK, and TX.
Product Description
Fresenius Naturalyte Liquid Acid Concentrate || Catalog Number: 08-2301-3 || Intended Use: Acid Concentrate for Bicarbonate Dialysis
Manufacturer
Fresenius Medical Care Renal Therapies Group, LLC
1 Event
Recall of Device Recall Fresenius Naturalyte Liquid Acid Concentrate
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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
One device with a similar name
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Device Recall Fresenius NaturaLyte Liquid 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 NaturaLyte Liquid Acid Concentrate || Product Codes: || 08-0231-4, 08-1001-0, 08-1201-8, 08-1231-3, 08-1251-1, 08-1301-4, 08-2201-5, 08-2231-2, 08-2251-0, 08-2301-3,08-2351-8,08-3201-4,08-3231-1,08-3251-9,08-3301-2,08-4123-1, 08-4223-7, 08-4225-1' 08-4230-2, 08-4231-0, 08-4323-5, 08-4325-1, 13-1251-1, 13-2201-5, 13-2231-2, 13-2251-0, || 13-3231-1,13-3251-9, 13-4123-1' 13-4220-1, 13-4225-1 ' 13-4325-1. || For the treatment of acute and chronic renal failure during hemodialysis procedure.
Manufacturer
Fresenius Medical Care Holdings, Inc.
Language
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