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Terminated

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

FDA Recall Z-0942-2021 · Posted None

Recalling FirmFresenius Medical Care Holdings, Inc.
Recall StatusTerminated
Product CodeKPO
Date Initiated2020-12-17
Date Terminated2023-01-05
Product Quantity2,280 cases (9,120 bottles)

Reason for Recall

Bottles Missing Product Label

Firm Action

Fresenius Medical Care (FMCRTG isssued URGENT MEDICAL DEVICE RECALL on 12/17/20 ia First Class Mail, letter states reason for recall, health risk and action to take: RETURN ONLY BOTTLES WITH NO LABEL OPEN AND CHECK ALL BOTTLES IN CASES of Lot Number 20NTAC040. " If you find any bottles from this lot with no labels, place the product in a secure, segregated area. Please contact FMCRTG Customer Service at 1-800-323-5188 for instructions on how to return the product and receive credit. o If returning single bottles, please place affected product in a box for pick up. Please contact FMCRTG Customer Service at 1-800-323-5188 if you have unique circumstances or an urgent need concerning product delivery.

Root Cause

Packaging change control

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K070177FRESENIUS NATURALYTE LIQUID ACID CONCENTRATE, 9000, 6000 AND 4000 SERIESFresenius Medical Care North America · 2007-03-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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