Fresenius Medical Care Holdings, Inc.: Medical Device Recall in 2022 - (Recall #: Z-0181-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallon bottles per bottle case. For dialysis.

Product Classification:

Class II

Date Initiated: October 4, 2022

Date Posted: November 16, 2022

Recall Number: Z-0181-2023

Event ID: 90947

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.

Status: Ongoing

Product Quantity: 17700

Code Information:

UDI-DI: 00840861101610 Lots: 20LTAC076 20PTAC094 21ATAC046 21BTAC082 21CTAC029 21KTAC072 21PTAC023 21STAC094 22DTAC036

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.

Voluntary or Mandated:

Voluntary: Firm initiated