FDA Device recall Z-2383-2024
Infusomat UNIV. 15 DROP PUMP SET W/ 3 ULTRASITE LL-Used with an electrically-powered infusion pump for intravenous (IV) administration of m…
- FDA Device
- Class II
- ongoing
- Published 2024-07-24
On 2024-07-24 the FDA classified a Class II recall of Infusomat UNIV. 15 DROP PUMP SET W/ 3 ULTRASITE LL-Used with an electrically-powered infusion pump for intravenous (IV) administration of m… by B Braun Medical, citing 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 prim….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2383-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-06-17 |
| Published | 2024-07-24 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | B Braun Medical |
| Distribution | US |
Product
Infusomat UNIV. 15 DROP PUMP SET W/ 3 ULTRASITE LL-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 362431
Reason
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.
Identifiers
| code_info | UDI-DI 04046964294013; All Lots Distributed After 02AUG2023. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2383-2024%22
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