FDAHealthOctober 29, 2025
B Braun Medical Inc — Anesthesia IV 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 Pu
⚠️ 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
- Anesthesia IV 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 SET W/15 DROPS/ML, 132 IN; Catalog Number: 490469. 2. IV ADMIN SET, 60D 2 CARESITE VLV, 132 IN; Catalog Number: 490470.
- Brand
- B Braun Medical Inc
- Lot code
- 1. Catalog Number: 490469; Primary UDI-DI: 04046964958816; Unit of Dose UDI-DI: 04046964958809. 2. Catalog Number: 490470; Primary UDI-DI: 04046964958830; Unit of Dose UDI-DI: 04046964958823.
Additional details
1. Catalog Number: 490469; Primary UDI-DI: 04046964958816; Unit of Dose UDI-DI: 04046964958809. 2. Catalog Number: 490470; Primary UDI-DI: 04046964958830; Unit of Dose UDI-DI: 04046964958823.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 104,784 units.
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