Monoject" 12 mL Syringe Luer-Lock Tip Soft Pack — Class I medical device recall Z-0147-2024
Ongoing recall by Cardinal Health 200, LLC, reported 2023-11-01, distributed nationwide. Demonstrated recognition and compatibility issues with syringe infusion pumps.
| Recall number | Z-0147-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardinal Health 200, LLC, Waukegan, IL, United States |
| Recall initiated | 2023-09-20 |
| Classified | 2023-10-26 |
| Reported by FDA | 2023-11-01 |
| Distributed | Nationwide (US) |
| Quantity | 3,084,300 units |
| UPC / GTIN / UDI-DI | 10192253025811, 20192253025818, 50192253025819 |
| Lot numbers | 221101, 221102, 221103, 221104 |
Product
Monoject" 12 mL Syringe Luer-Lock Tip Soft Pack
Reason for recall
Demonstrated recognition and compatibility issues with syringe infusion pumps.
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/Z-0147-2024. 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.