0 — Class I drug recall D-0350-2020
Terminated recall by ICU Medical Inc, reported 2019-11-13, distributed nationwide. Presence of Particulate Matter.
| Recall number | D-0350-2020 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ICU Medical Inc, Lake Forest, IL, United States |
| Recall initiated | 2019-10-25 |
| Classified | 2019-11-15 |
| Reported by FDA | 2019-11-13 |
| Terminated | 2022-01-20 |
| Distributed | Nationwide (US) |
| Quantity | 58,464 bags |
| Reason classes | specification failure |
| NDC | 00409-7983-25 |
| Lot numbers | 95-101-C6 |
| Expiration dates | 2020-05-01 |
Product
0.9% SODIUM CHLORIDE INJECTION, USP, 250 mL VisIV Container, Rx Only, Hospira, Inc. Lake Forest, IL 60045. NDC 0409-7983-25
Reason for recall
Presence of Particulate Matter.
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-0350-2020. 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.