0 — Class II drug recall D-0884-2018
Terminated recall by ICU Medical Inc, reported 2018-06-27, distributed nationwide. Lack of assurance of sterility: Bags have potential to leak.
| Recall number | D-0884-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ICU Medical Inc, LAKE FOREST, IL, United States |
| Recall initiated | 2018-05-31 |
| Classified | 2018-06-20 |
| Reported by FDA | 2018-06-27 |
| Terminated | 2020-06-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 1,247,200 bags |
| Reason classes | sterility, packaging |
| NDC | 00409-7984-37 |
| Lot numbers | 01/012020, 85-021-JT, 86-001-JT |
| Expiration dates | 2020-02-01 |
Product
0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only ,Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7984-37
Reason for recall
Lack of assurance of sterility: Bags have 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-0884-2018. 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.