Naturalyte Liquid Bicarbonate Concentrate 6 — Class II medical device recall Z-2373-2015
Ongoing recall by Fresenius Medical Care Holdings, Inc., reported 2015-08-19, distributed nationwide. Expansion of recall to lots manufactured in 2015 due to the potential for bacterial contamination.
| Recall number | Z-2373-2015 |
|---|---|
| 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 | 2015-07-16 |
| Classified | 2015-08-12 |
| Reported by FDA | 2015-08-19 |
| Distributed | Nationwide (US) |
| Quantity | 2,264,028 |
| Reason classes | microbial contamination |
Product
Naturalyte Liquid Bicarbonate Concentrate 6.4 liter bottle A Dialysate Concentrate for Hemodialysis (liquid) Product Code: 08-4000-LB
Reason for recall
Expansion of recall to lots manufactured in 2015 due to the potential for bacterial contamination.
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-2373-2015. 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.