FDA Device recall Z-2086-2021
Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate are each intended to be used as one component in the preparation o…
- FDA Device
- Class II
- terminated
- Published 2021-07-28
On 2021-07-28 the FDA classified a Class II recall of Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate are each intended to be used as one component in the preparation o… by Fresenius Medical Care Holdings, citing exposed to freezing temperatures due to refrigerated truck malfunctions.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2086-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-04-28 |
| Published | 2021-07-28 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Fresenius Medical Care Holdings |
| Distribution | TX |
Product
Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate are each intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician s prescription. Both concentrates are formulated for use in 45X proportioning systems which proportion a nominal ratio of 1 : 1.72 : 42.28 (acid : bicarbonate : water) to generate dialysate. The dialysate is intended to be pumped through a dialyzer, creating an osmotic gradient across the dialyzer membrane to exchange solutes with blood during hemodialysis.
Reason
Exposed to freezing temperatures due to refrigerated truck malfunctions
Identifiers
| code_info | Lot Number/UDI: (1)21BTAC004 UDI: (01)00840861101535 (2)21AGAC026 UDI: (01)00840861101696 (3)21BTAC008 UDI: (01)00840861101740 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2086-2021%22
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