FDA Device recall Z-0839-2021
Naturalyte Liquid Acid concentrate drums, Product Code 13-2251-0 - 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, Product Code 13-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sod… by Fresenius Medical Care Holdings, citing the deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously co….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0839-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-11-23 |
| 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, Product Code 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
The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification.
Identifiers
| code_info | Lot Numbers: 20LXAC025 20LXAC081 20LXAC082 20LXAC083 Additional Affected lots as of 3/17/21: 20LXAC029 20NXAC021…Lot Numbers: 20LXAC025 20LXAC081 20LXAC082 20LXAC083 Additional Affected lots as of 3/17/21: 20LXAC029 20NXAC021 20LXAC026 20LXAC065 20LXAC028 20NXAC029 20LXAC071 20LXAC103 20LXAC027 20LXAC070 20LXAC067 20NXAC019 20LXAC082 20LXAC025 20LXAC081 20LXAC083 |
|---|
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-0839-2021%22
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