NaturaLyte Liquid Bicarbonate Concentrate — Class II medical device recall Z-1827-2015
Ongoing recall by Fresenius Medical Care Holdings, Inc., reported 2015-07-01, distributed nationwide. Bacterial contamination.
| Recall number | Z-1827-2015 |
|---|---|
| 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 | 2015-05-20 |
| Classified | 2015-06-22 |
| Reported by FDA | 2015-07-01 |
| Distributed | Nationwide (US) |
| Quantity | 1,856,619 bottles |
| Reason classes | microbial contamination |
| Model numbers | 08-4000-LB |
Product
NaturaLyte Liquid Bicarbonate Concentrate (Dialysate Concentrate for Hemodialysis (liquid), 6.4 Liter Bottle Catalog Number: 08-4000-LB This concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates.
Reason for recall
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-1827-2015. 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.