0 — Class II drug recall D-0062-2023
Ongoing recall by ICU Medical Inc, reported 2022-11-23, distributed nationwide. Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromis
| Recall number | D-0062-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ICU Medical Inc, Lake Forest, IL, United States |
| Recall initiated | 2022-11-09 |
| Classified | 2022-11-16 |
| Reported by FDA | 2022-11-23 |
| Distributed | Nationwide (US) |
| Quantity | 137,120 bags |
| Reason classes | sterility, packaging |
| NDC | 00990-7730, 00990-7730-36, 00990-7730-37, 00990-7983, 00990-7983-02, 00990-7983-03, 00990-7983-09, 00990-7983-53, 00990-7983-55, 00990-7983-61, 00990-7984, 00990-7984-13, 00990-7984-20, 00990-7984-23, 00990-7984-36, 00990-7984-37, 00990-7985, 00990-7985-02, 00990-7985-03, 00990-7985-09 |
| Lot numbers | 5829936 |
| Expiration dates | 2024-03-31 |
Product
0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37
Reason for recall
Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise 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-0062-2023. 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.