Fresenius Naturalyte Liquid Bicarbonate Concentrate Product Number:… — Class II medical device recall Z-2686-2014
Terminated recall by Fresenius Medical Care Holdings, Inc., reported 2014-10-01, distributed in TX. Product was held at temperature above the labeled recommended storage temperature
| Recall number | Z-2686-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Medical Care Holdings, Inc., Waltham, MA, United States |
| Recall initiated | 2014-06-23 |
| Classified | 2014-09-23 |
| Reported by FDA | 2014-10-01 |
| Terminated | 2021-01-29 |
| Distributed | TX |
| Quantity | 72 cases |
| Reason classes | labeling |
| Lot numbers | 14BMLB012 |
Product
Fresenius Naturalyte Liquid Bicarbonate Concentrate Product Number: 08-4000-LB The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates.
Reason for recall
Product was held at temperature above the labeled recommended storage temperature
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-2686-2014. 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.