Z-0181-2023 Class II Ongoing
FDA device recall Z-0181-2023 was initiated by Fresenius Medical Care Holdings, Inc. on Oct 4, 2022 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 17700.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 16, 2022
- Initiation Date
- Oct 4, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17700
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.
Distribution Pattern
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.
Code Information
UDI-DI: 00840861101610 Lots: 20LTAC076 20PTAC094 21ATAC046 21BTAC082 21CTAC029 21KTAC072 21PTAC023 21STAC094 22DTAC036
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0181-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026