FDAFDA · Food and drugs·Recall number Z-0603-2026
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.
Published December 3, 2025 · Recall initiated: October 29, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- B Braun Medical Inc
- Distributor
- Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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