FDA Device recall Z-0815-2021
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies S…
- 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 bottles, Model Number 08-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies S… 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-0815-2021 |
| 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 bottles, Model Number 08-2251-0 - 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 sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
Identifiers
| code_info | Lot Numbers: 20LXAC048 20LXAC053 20LXAC047 20NXAC016 20LXAC094 20NXAC009 20LXAC049 20LXAC054 20NXAC025 20NXAC0…Lot Numbers: 20LXAC048 20LXAC053 20LXAC047 20NXAC016 20LXAC094 20NXAC009 20LXAC049 20LXAC054 20NXAC025 20NXAC024 Additional Affected lots as of 3/17/21: 20LXAC076 20LXAC077 20LXAC091 20LXAC101 20NXAC010 20NXAC016 |
|---|
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-0815-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.