Z-2392-2024 Class II Ongoing
FDA device recall Z-2392-2024 was initiated by B. Braun Medical, Inc. on Jun 17, 2024 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 2085606 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 24, 2024
- Initiation Date
- Jun 17, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2085606 units
Product Description
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.
Distribution Pattern
Worldwide distribution - US Nationwide and the country of Canada.
Code Information
UDI-DI 04046964294679; All Lots Distributed After 01AUG2023.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2392-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026