0 — Class II drug recall D-0827-2018
Terminated recall by Fresenius Medical Care Renal Therapies Group, LLC, reported 2018-05-30, distributed nationwide. Lack of Assurance of Sterility
| Recall number | D-0827-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Medical Care Renal Therapies Group, LLC, Waltham, MA, United States |
| Recall initiated | 2017-11-13 |
| Classified | 2018-05-22 |
| Reported by FDA | 2018-05-30 |
| Terminated | 2018-12-06 |
| Distributed | Nationwide (US) |
| Reason classes | sterility |
| NDC | 49230-0300-10 |
| Lot numbers | 09/18, 17LU05005 |
| Model numbers | 060-10109 |
Product
0.9% Sodium Chloride Injection, USP, 1000 mL, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-0300-10.
Reason for recall
Lack of Assurance of Sterility
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/D-0827-2018. 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.