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Recall

Class II — Fresenius Medical Care Holdings, Inc.

Recalling firmFresenius Medical Care Holdings, Inc.
Registered facilityView this company's 2 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonBottles Missing Product Label
ProductFresenius Medical Care NaturaLyte Liquid Acid concentrate-Liquid Acid Concentrate for Bicarbonate Hemodialyis Part Number: 08-3251-9
Quantity2,280 cases (9,120 bottles)
DistributionNationwide
Initiated2020-12-17
Classified2021-02-01
Terminated2023-01-05
Recall numberZ-0942-2021
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Fresenius Medical Care Holdings, Inc. (Z-0942-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87006/

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