FDA Enforcement
Class II
Ongoing
Infusomat 60 DROP METRISET PUMP SET,3 SFLINE ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363010
Recall: Z-2385-2024
·
Reported July 24, 2024
Enforcement
- Recall Number
- Z-2385-2024
- Event ID
- 94823
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- B. Braun Medical, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 24, 2024
- Initiation Date
- June 17, 2024
- Classification Date
- July 17, 2024
- Address
- 901 Marcon Blvd, Allentown, PA, 18109-9512, United States
Description
Infusomat 60 DROP METRISET PUMP SET,3 SFLINE ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363010
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.
Code Info
UDI-DI 04046964294174; All Lots Distributed After 05SEP2023.
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
Quantity
100 units