Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
NaturaLyte¿ Liquid Bicarbonate Concentrate Recalled by Fresenius Medical Care Holdings, Inc. Due to Foreign Object Contamination
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
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.
Quantity: 12 bottles
Why Was This Recalled?
Container cap may contain foreign material- 0.60% - 0.80% Manganese
Where Was This Sold?
This product was distributed to 1 state: MO
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