FDA Device recall Z-2110-2018
NaturaLyte¿ Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liters, Part Number: 08-3231-1 Product Usage: This concentrate is formul…
- FDA Device
- Class II
- terminated
- Published 2018-06-13
On 2018-06-13 the FDA classified a Class II recall of NaturaLyte¿ Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liters, Part Number: 08-3231-1 Product Usage: This concentrate is formul… by Fresenius Medical Care Renal Therapies Group, citing the bottles are mislabeled with an incorrect part number.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2110-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-05-02 |
| Published | 2018-06-13 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Fresenius Medical Care Renal Therapies Group |
| Distribution | US |
Product
NaturaLyte¿ Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liters, Part Number: 08-3231-1 Product Usage: This concentrate is formulated to be used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine. For every 45 volume parts of dialysate: 1 volume part of the NaturaLyte acid concentrate, 1.72 volume parts of FMCNA Sodium Bicarbonate Concentrate and 42.28 volume parts of Purified Water (AAMI quality) are used.
Reason
The bottles are mislabeled with an incorrect part number.
Identifiers
| code_info | Lot Code: 18CXAC095 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2110-2018%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.