NaturaLyte¿ Liquid Acid Concentrate 2.0 mEq/L, Model # 08-2251-0 3.43 liter bottle This 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.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot # 17KTAC076; UDI-00840861101696
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Fresenius Medical Care Renal Therapies Group, LLC
Reason for Recall:
The label specifies the potassium concentration is 2.0 mEq/L. Some of the product in the affected lot was found to have a potassium concentration of 2.25 mEq/L.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

NaturaLyte¿ Liquid Acid Concentrate 2.0 mEq/L, Model # 08-2251-0 3.43 liter bottle This 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.

Product Codes/Lot Numbers:

Lot # 17KTAC076; UDI-00840861101696

Distribution:

Distributed in: US, CA, FL, KS, LA, TX

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1010-2018

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