Naturalyte Liquid Bicarbonate Concentrate — Class I medical device recall Z-1639-2014
Ongoing recall by Fresenius Medical Care Holdings, Inc., reported 2014-05-28, distributed nationwide. Naturalyte Liquid Bicarbonate maybe contaminated
| Recall number | Z-1639-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Medical Care Holdings, Inc., Waltham, MA, United States |
| Recall initiated | 2014-04-10 |
| Classified | 2014-05-22 |
| Reported by FDA | 2014-05-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 672,784 units |
| Lot numbers | 13LMLB005, 13LMLB006, 14AMLB011, 14AMLB013, 14AMLB014, 14AMLB015, 14AMLB016, 14AMLB017, 14BLMB001 |
| Model numbers | 08-4000-LB |
Product
Naturalyte Liquid Bicarbonate Concentrate, 6.4 Liter Bottle Part 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
Naturalyte Liquid Bicarbonate maybe contaminated
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-1639-2014. 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.