FDA Device recall Z-0826-2021
NaturaLyte Liquid Acid concentrate drums, Model Number 13-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies Sod…
- FDA Device
- Class II
- ongoing
- Published 2021-01-20
On 2021-01-20 the FDA classified a Class II recall of NaturaLyte Liquid Acid concentrate drums, Model Number 13-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies Sod… by Fresenius Medical Care Holdings, citing the sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0826-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-11-07 |
| Published | 2021-01-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Fresenius Medical Care Holdings |
| Distribution | US |
Product
NaturaLyte Liquid Acid concentrate drums, Model Number 13-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
Reason
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
Identifiers
| code_info | Lot Numbers: 20LXAC024 20LXAC072 20LXAC073 20LXAC085 20NXAC017 20NXAC030 20LXAC074 20LXAC023 20LXAC104 Addit…Lot Numbers: 20LXAC024 20LXAC072 20LXAC073 20LXAC085 20NXAC017 20NXAC030 20LXAC074 20LXAC023 20LXAC104 Additional affected lots as of 3/17/21: 20LXAC066 20LXAC089 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0826-2021%22
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