NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallon bottles per bottle case. For dialysis.
Reported: November 16, 2022 Initiated: October 4, 2022 #Z-0181-2023
Product Description
NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallon bottles per bottle case. For dialysis.
Reason for Recall
The "Nominal Chemical Composition" section of the label incorrectly lists 5.62g/L KCL (potassium chloride). 5.62g/L actually corresponds to the CaCl (calcium chloride) content. The product remains potassium free.
Details
- Recalling Firm
- Fresenius Medical Care Holdings, Inc.
- Units Affected
- 17700
- Distribution
- Domestic distribution to AL AZ CA DC FL GA HI IL IN MD MI MO MS NE NJ NY OH PA SD TX VA No foreign distribution.
- Location
- Waltham, MA
Frequently Asked Questions
What product was recalled? ▼
NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallon bottles per bottle case. For dialysis.. Recalled by Fresenius Medical Care Holdings, Inc.. Units affected: 17700.
Why was this product recalled? ▼
The "Nominal Chemical Composition" section of the label incorrectly lists 5.62g/L KCL (potassium chloride). 5.62g/L actually corresponds to the CaCl (calcium chloride) content. The product remains potassium free.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 16, 2022. Severity: Moderate. Recall number: Z-0181-2023.
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