Infusomat UNIV — Class II medical device recall Z-2392-2024
Ongoing recall by B. Braun Medical, Inc., reported 2024-07-24, distributed nationwide. Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggybac
| Recall number | Z-2392-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | B. Braun Medical, Inc., Allentown, PA, United States |
| Recall initiated | 2024-06-17 |
| Classified | 2024-07-17 |
| Reported by FDA | 2024-07-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 2,085,606 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 04046964294679 |
| Model numbers | 363430 |
Product
Infusomat UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363430
Reason for recall
Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.
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-2392-2024. 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.