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Recall Observatory FDA recall evidence

Device product

Fresenius Medical Care NaturaLyte Liquid Acid concentrate-Liquid Acid Concentrate for Bicarbonate Hemodialyis Part Number: 08-3251-9

Z-0942-2021

December 17, 2020

Class II

Product summary

Firm
Fresenius Medical Care Holdings, Inc.
Event
Event 87006
Status
Terminated
Classification
Class II
Quantity
2,280 cases (9,120 bottles)
Official record key
device-enforcement:Z-0942-2021

Official wording

Reason: Bottles Missing Product Label

Code information: Lot code: 20NTAC040

Distribution pattern: Nationwide

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Missing Product Label