Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2110-2018 — NaturaLyte¿ Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liters, Part Number: 08-3231-1 Product Usage: This concentrate is formulated to be used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (

U.S. FDA — Device Enforcement · United States · 2018-05-02 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2110-2018
Date of alert: 2018-05-02
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Fresenius Medical Care Renal Therapies Group, LLC
Product category: device
Product type: Devices

Reported risk: The bottles are mislabeled with an incorrect part number.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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