Devices

Device Recall Naturalyte Liquid Bicarbonate Concentrate

Model / Serial
Lots begin with: 15AMLB, 15BMLB, 15CMLB.
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution
Product Description
Naturalyte Liquid Bicarbonate Concentrate 6.4 liter bottle || A Dialysate Concentrate for Hemodialysis (liquid) || Product Code: 08-4000-LB
Manufacturer
Fresenius Medical Care Holdings, Inc.
1 Event
- Recall of Device Recall Naturalyte Liquid Bicarbonate Concentrate

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

One device with a similar name

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Device Recall NaturaLyte Liquid Bicarbonate Concentrate

Model / Serial
Lot Number: 14CMLB006
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Distributed in the state of MO.
Product Description
NaturaLyte¿ Liquid Bicarbonate Concentrate, 6.4 liter bottle to be used with a hemodialysis unit; Part Number: 08-4000-LB. || The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates.
Manufacturer
Fresenius Medical Care Holdings, Inc.

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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