NaturaLyte¿ Liquid Acid Concentrate for Bicarbonate Dialysis — Class II medical device recall Z-2110-2018
Terminated recall by Fresenius Medical Care Renal Therapies Group, LLC, reported 2018-06-13, distributed nationwide. The bottles are mislabeled with an incorrect part number.
| Recall number | Z-2110-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Medical Care Renal Therapies Group, LLC, Waltham, MA, United States |
| Recall initiated | 2018-05-02 |
| Classified | 2018-06-07 |
| Reported by FDA | 2018-06-13 |
| Terminated | 2020-05-13 |
| Distributed | Nationwide (US) |
| Reason classes | labeling |
| Lot numbers | 18CXAC095 |
| Model numbers | 08-3231-1 |
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 for recall
The bottles are mislabeled with an incorrect part number.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2110-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.