Fresenius Naturalyte Liquid Acid Concentrate Catalog Number:… — Class II medical device recall Z-0887-2016
Terminated recall by Fresenius Medical Care Renal Therapies Group, LLC, reported 2016-03-02, distributed in KS, LA, MS, OK, TX. On the label calcium (Ca) listed in the right upper corner of the label (red background) incorrectly indicates
| Recall number | Z-0887-2016 |
|---|---|
| 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 | 2016-01-18 |
| Classified | 2016-02-25 |
| Reported by FDA | 2016-03-02 |
| Terminated | 2017-08-14 |
| Distributed | KS, LA, MS, OK, TX |
| Reason classes | labeling |
| Lot numbers | 15STAC072 |
| Model numbers | 08-2301-3 |
| Expiration dates | 2017-12-31 |
Product
Fresenius Naturalyte Liquid Acid Concentrate Catalog Number: 08-2301-3 Intended Use: Acid Concentrate for Bicarbonate Dialysis
Reason for recall
On the label calcium (Ca) listed in the right upper corner of the label (red background) incorrectly indicates the product contains 2.5 mEq/L Ca. The concentration indicated in the list of constituents represents the actual calcium concentration of the final dialysate, 3.0 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-0887-2016. 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.