B Braun Medical Inc — ADDitIV 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. Label
⚠️ 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
- ADDitIV 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 numbers: 1. Primary Gravity IV Set, 2 Non-Needle-Free Injection Sites; Catalog Number: V1443. 2. ADDITIVE SET W/ 3 INJ SITES -DR*; Catalog Number: V1447. 3. ADD PEDIATRIC 3 INJ LUER LOCK; Catalog Number: V1448. 4. ADULT ADD 2 INJ CKV LUER LOCK; Catalog Number: V1484.
- Brand
- B Braun Medical Inc
- Lot code
- 1. Catalog Number: V1443; Primary UDI-DI: 04046964188350; Unit of Use UDI-DI: 04046964188343. 2. Catalog Number: V1447; Primary UDI-DI: 04046964188411; Unit of Use UDI-DI: 04046964188404. 3. Catalog Number: V1448; Primary UDI-DI: 04046964188435; Unit of Use UDI-DI: 04046964188428. 4. Catalog Number: V1484; Primary UDI-DI: 04046964188473; Unit of Use UDI-DI: 04046964188466.
Additional details
1. Catalog Number: V1443; Primary UDI-DI: 04046964188350; Unit of Use UDI-DI: 04046964188343. 2. Catalog Number: V1447; Primary UDI-DI: 04046964188411; Unit of Use UDI-DI: 04046964188404. 3. Catalog Number: V1448; Primary UDI-DI: 04046964188435; Unit of Use UDI-DI: 04046964188428. 4. Catalog Number: V1484; Primary UDI-DI: 04046964188473; Unit of Use UDI-DI: 04046964188466.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 43,900 units.
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