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Fresenius Medical Care Holdings, Inc. recalls (1) 08-4078-BB BIBAG 650 GRAMS/BAG 16 BAGS/CASE (2) 08-4080-BB BIBAG 900 grams/bag 12 bags/case For patients wit
Recalled July 28, 2021 · FDA recall Z-2082-2021 · Fresenius Medical Care Holdings
Hazard
Exposed to freezing temperatures due to refrigerated truck malfunctions · FDA Class II
Units
(1) 20 cases (2) 30 cases
Sold at
US Distribution to: TX only
Description
Exposed to freezing temperatures due to refrigerated truck malfunctions
Product
(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.
Manufacturer(s)
Fresenius Medical Care Holdings, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →