Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
(1) 08-4078-BB BIBAG 650 GRAMS/BAG 16 BAGS/CASE (2) 08-4080-BB BIBAG Recalled by Fresenius Medical Care Holdings, Inc. Due to Exposed to freezing temperatures due to refrigerated truck...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Fresenius Medical Care Holdings, Inc. directly.
Affected 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.
Quantity: (1) 20 cases (2) 30 cases
Why Was This Recalled?
Exposed to freezing temperatures due to refrigerated truck malfunctions
Where Was This Sold?
This product was distributed to 1 state: TX
About Fresenius Medical Care Holdings, Inc.
Fresenius Medical Care Holdings, Inc. has 161 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report