NaturaLyte¿ Liquid Acid Concentrate 2 — Class II medical device recall Z-1010-2018
Terminated recall by Fresenius Medical Care Renal Therapies Group, LLC, reported 2018-03-21, distributed in CA, FL, KS, LA, TX. The label specifies the potassium concentration is 2.0 mEq/L. Some of the product in the affected lot was foun
| Recall number | Z-1010-2018 |
|---|---|
| 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 | 2017-09-29 |
| Classified | 2018-03-14 |
| Reported by FDA | 2018-03-21 |
| Terminated | 2018-08-09 |
| Distributed | CA, FL, KS, LA, TX |
| Quantity | 598 cases |
| Reason classes | labeling |
| Lot numbers | 17KTAC076 |
| Model numbers | 08-2251-0, 3.43 |
Product
NaturaLyte¿ Liquid Acid Concentrate 2.0 mEq/L, Model # 08-2251-0 3.43 liter bottle 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.
Reason for recall
The label specifies the potassium concentration is 2.0 mEq/L. Some of the product in the affected lot was found to have a potassium concentration of 2.25 mEq/L.
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-1010-2018. 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.