Fresenius Medical Care NaturaLyte Liquid Acid concentrate-Liquid Acid Concentrate for Bicarbonate...
FDA Recall #Z-0942-2021 — Class II — December 17, 2020
Product Description
Fresenius Medical Care NaturaLyte Liquid Acid concentrate-Liquid Acid Concentrate for Bicarbonate Hemodialyis Part Number: 08-3251-9
Reason for Recall
Bottles Missing Product Label
Recalling Firm
Fresenius Medical Care Holdings, Inc. — Waltham, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
2,280 cases (9,120 bottles)
Distribution
Nationwide
Code Information
Lot code: 20NTAC040
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated