FDAHealthOctober 29, 2025
B Braun Medical Inc — IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basi
⚠️ Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Is this relevant to me?
- Geography
- US
- Source agency
- FDA
- Category
- Health
- Published
- October 29, 2025
Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
What's affected?
- Product
- IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN 15D, 2 B/C VLV, 3 CARESITE LADS; Catalog Number: 490653.
- Brand
- B Braun Medical Inc
- Lot code
- 1. Catalog Number: 490653; Primary UDI-DI: 04046955836338; Unit of Dose UDI-DI: 04046955836345.
Additional details
1. Catalog Number: 490653; Primary UDI-DI: 04046955836338; Unit of Dose UDI-DI: 04046955836345.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 48 units.
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