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Recall Observatory FDA recall evidence

Device product

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

Z-0181-2023

October 04, 2022

Class II

Product summary

Firm
Fresenius Medical Care Holdings, Inc.
Event
Event 90947
Status
Ongoing
Classification
Class II
Quantity
17700
Official record key
device-enforcement:Z-0181-2023

Official wording

Reason: 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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.