Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate are each intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician s prescription. Both concentrates are formulated for use in 45X proportioning systems which proportion a nominal ratio of 1 : 1.72 : 42.28 (acid : bicarbonate : water) to generate dialysate. The dialysate is intended to be pumped through a dialyzer, creating an osmotic gradient across the dialyzer membrane to exchange solutes with blood during hemodialysis.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot Number/UDI: (1)21BTAC004 UDI: (01)00840861101535 (2)21AGAC026 UDI: (01)00840861101696 (3)21BTAC008 UDI: (01)00840861101740
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
β οΈ 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 Holdings, Inc.
- Reason for Recall:
- Exposed to freezing temperatures due to refrigerated truck malfunctions
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate are each intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician s prescription. Both concentrates are formulated for use in 45X proportioning systems which proportion a nominal ratio of 1 : 1.72 : 42.28 (acid : bicarbonate : water) to generate dialysate. The dialysate is intended to be pumped through a dialyzer, creating an osmotic gradient across the dialyzer membrane to exchange solutes with blood during hemodialysis.
Product Codes/Lot Numbers:
Lot Number/UDI: (1)21BTAC004 UDI: (01)00840861101535 (2)21AGAC026 UDI: (01)00840861101696 (3)21BTAC008 UDI: (01)00840861101740
Distribution:
Distributed in: US, TX
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2086-2021
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