NaturaLyte Liquid Acid concentrate drums, Model Number 13-2251-0 - Product Usage: used in conjunc...

FDA Device Recall #Z-0825-2021 — Class II — November 7, 2020

Recall Summary

Recall Number Z-0825-2021
Classification Class II — Moderate risk
Date Initiated November 7, 2020
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Fresenius Medical Care Holdings, Inc.
Location Waltham, MA
Product Type Devices
Quantity 592 drums

Product Description

NaturaLyte Liquid Acid concentrate drums, Model Number 13-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

Reason for Recall

The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.

Distribution Pattern

US Nationwide distribution.

Lot / Code Information

Lot Numbers: 20LXAC070 20LXAC103 20NXAC021 20LXAC100 20LXAC026 20LXAC027 20LXAC028 20LXAC029 20LXAC065 20LXAC067 20LXAC071 20NXAC001 20NXAC019 20NXAC020 20NXAC029 Additional affected lots as of 3/17/21: 20LXAC103 20LXAC082 20LXAC025 20LXAC081 20LXAC083

Other Recalls from Fresenius Medical Care Holdings, Inc.

Recall # Classification Product Date
Z-0936-2026 Class II 5008X CAREsystem +CLiC +CDX; Oct 25, 2025
Z-0041-2026 Class II Optiflux¿ High Flux E-beam Dialyzer Model Numb... Aug 29, 2025
Z-1992-2025 Class II 5008X HDF Hemodialysis Blood Tubing Set, 24 uni... Apr 29, 2025
Z-0801-2025 Class II Dialyzer Optiflux 160NRe Dec 5, 2024
Z-3124-2024 Class II Blood Pressure Module BPM3 TM-2917B (Spare Part... Aug 8, 2024

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.