0 — Class II drug recall D-1091-2017
Terminated recall by ICU Medical Inc, reported 2017-08-23, distributed nationwide. Presence of Particulate Matter; stainless steel
| Recall number | D-1091-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ICU Medical Inc, Lake Forest, IL, United States |
| Recall initiated | 2017-07-26 |
| Classified | 2017-08-14 |
| Reported by FDA | 2017-08-23 |
| Terminated | 2019-03-11 |
| Distributed | Nationwide (US) |
| Quantity | 436,716 flexible |
| Reason classes | specification failure |
| NDC | 00409-7983-09 |
| Lot numbers | 61-841-FW |
| Expiration dates | 2018-01-01 |
Product
0.9% Sodium Chloride Injection, USP in 1000 mL Single Dose Flexible Container, Hospira, Inc., Lake Forest, IL 60045 USA --- NDC# 0409-7983-09
Reason for recall
Presence of Particulate Matter; stainless steel
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-1091-2017. 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.