NaturaLyte Liquid Acid concentrate bottles — Class II medical device recall Z-0811-2021
Ongoing recall by Fresenius Medical Care Holdings, Inc., reported 2021-01-20, distributed nationwide. The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
| Recall number | Z-0811-2021 |
|---|---|
| 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 | 2020-11-07 |
| Classified | 2021-01-11 |
| Reported by FDA | 2021-01-20 |
| Distributed | Nationwide (US) |
| Quantity | 3,665 cases |
| Lot numbers | 20LXAC063, 20LXAC098, 20NXAC005, 20NXAC008, 20NXAC037, 20NXAC039 |
| Model numbers | 08-1251-1 |
Product
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-1251-1 - 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 sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
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-0811-2021. 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.