FDA-Device2021-07-28Class II
(1) 08-4078-BB BIBAG 650 GRAMS/BAG 16 BAGS/CASE (2) 08-4080-BB BIBAG 900 grams/bag 12 bags/case For patients with acute and chronic end stage renal disease going under PD in healthcare or home setting GRANUFLO & NATURALYTE: Concentrate is formulated to be used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
Fresenius Medical Care Holdings, Inc.
Hazard
Exposed to freezing temperatures due to refrigerated truck malfunctions
Sold states
US Distribution to: TX only
Affected count
(1) 20 cases (2) 30 cases
Manufactured in
920 Winter St Bld 950, N/A, Waltham, MA, United States
Products
(1) 08-4078-BB BIBAG 650 GRAMS/BAG 16 BAGS/CASE (2) 08-4080-BB BIBAG 900 grams/bag 12 bags/case For patients with acute and chronic end stage renal disease going under PD in healthcare or home setting GRANUFLO & NATURALYTE: Concentrate is formulated to be used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2082-2021Don't want to check this manually?
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