Z-2398-2024 Class II Ongoing
FDA device recall Z-2398-2024 was initiated by B. Braun Medical, Inc. on June 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 patie… The recall status is ongoing. Affected quantity: 33065 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 24, 2024
- Initiation Date
- June 17, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 33065 units
Product Description
Infusomat 60 DROP METRISET PUMP SET, 3 CARESITES Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number: 490101
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 04046964186103; All Lots Distributed After 01AUG2023