NaturaLyte¿ Liquid Bicarbonate Concentrate — Class III medical device recall Z-1739-2014
Terminated recall by Fresenius Medical Care Holdings, Inc., reported 2014-06-18. Container cap may contain foreign material- 0.60% - 0.80% Manganese
| Recall number | Z-1739-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Medical Care Holdings, Inc., Waltham, MA, United States |
| Recall initiated | 2014-05-01 |
| Classified | 2014-06-09 |
| Reported by FDA | 2014-06-18 |
| Terminated | 2016-06-15 |
| Quantity | 12 bottles |
| Reason classes | foreign material |
| Lot numbers | 14CMLB006 |
| Model numbers | 08-4000-LB |
Product
NaturaLyte¿ Liquid Bicarbonate Concentrate, 6.4 liter bottle to be used with a hemodialysis unit; 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
Container cap may contain foreign material- 0.60% - 0.80% Manganese
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-1739-2014. 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.