B. Braun Medical, Inc. Recall 94823
Description: Infusomat UNIV. 15 DR PUMP SET, 1.2FIL, 2CRSTE ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363424
B. Braun Medical, Inc. Recall 94823 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2391-2024 |
| Event ID | 94823 |
| Event Description | Infusomat UNIV. 15 DR PUMP SET, 1.2FIL, 2CRSTE ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363424 |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide and the country of Canada. |
| Quantity | 32752 units |
| Recall 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. |
| Device Classification | 20240724 |
| Device Code Info | UDI-DI 04046964837906; All Lots Distributed After 01AUG2023. |
| Center Classification Date | 20240717 |
| Recall Initiation Date | 20240617 |
| Recalling Firm | B. Braun Medical, Inc. |
| Initial Notification | Letter |
| Similar To |