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. PB1500 15 DROP IV SET W/2 STOPCOCKS; Catalog Number: 490025.
- Brand
- B Braun Medical Inc
- Lot code
- 1. Catalog Number: 490025; Primary UDI-DI: 04046964301056; Unit of Dose UDI-DI: 04046964301049; Expiration Date: Earliest Exp of Comp or 60mths.
Additional details
1. Catalog Number: 490025; Primary UDI-DI: 04046964301056; Unit of Dose UDI-DI: 04046964301049; Expiration Date: Earliest Exp of Comp or 60mths.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 15,250 units.
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