0 — Class II drug recall D-0216-2019
Terminated recall by ICU Medical Inc, reported 2018-11-14, distributed nationwide. Lack of Assurance of Sterility; bags have the potential to leak
| Recall number | D-0216-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ICU Medical Inc, LAKE FOREST, IL, United States |
| Recall initiated | 2018-10-08 |
| Classified | 2018-11-02 |
| Reported by FDA | 2018-11-14 |
| Terminated | 2021-03-08 |
| Distributed | Nationwide (US) |
| Quantity | 2,580,448 bags |
| Reason classes | sterility, packaging |
| NDC | 00409-7983-02, 00409-7983-61, 00409-7984-36, 00409-7984-37 |
| Expiration dates | 2019-06-01, 2019-12-01, 2020-01-01 |
Product
0.9% Sodium Chloride Injection, USP Rx Only a) 250 mL NDC 0409-7983-02; b) 150 mL NDC 0409-7983-61; c) 50 mL NDC 0409-7984-36; d) 100 mL NDC 0409-7984-37, Hospira, Inc. Lake Forest, IL 60045
Reason for recall
Lack of Assurance of Sterility; bags have the potential to leak
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-0216-2019. 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.