Naturalyte Liquid Acid concentrate bottles — Class II medical device recall Z-0837-2021
Ongoing recall by Fresenius Medical Care Holdings, Inc., reported 2021-01-20, distributed nationwide. The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or app
| Recall number | Z-0837-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Medical Care Holdings, Inc., Waltham, MA, United States |
| Recall initiated | 2020-11-23 |
| Classified | 2021-01-11 |
| Reported by FDA | 2021-01-20 |
| Distributed | Nationwide (US) |
| Quantity | 5,079 cases |
| Lot numbers | 20LXAC043, 20LXAC044, 20LXAC045, 20LXAC058, 20LXAC059, 20LXAC060, 20LXAC078, 20LXAC079, 20LXAC096, 20NXAC011, 20NXAC012, 20NXAC026 |
Product
Naturalyte Liquid Acid concentrate bottles, Product Code 08-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
Reason for recall
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.
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-0837-2021. 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.