FDAHealthOctober 29, 2025
B Braun Medical Inc — Caresite 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. Labe
⚠️ 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
- Caresite 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 with 2 CARESITE¿ Injection Sites; IV ADMIN SET 15 DROP W/2 CARESITE; Catalog Number: 354202. 2. Primary Gravity IV Set with 2 CARESITE¿ Injection Sites; IV ADM 15DROP W/2 CARESITE SLIDECLMP; Catalog Number: 354203.
- Brand
- B Braun Medical Inc
- Lot code
- 1. Catalog Number: 354202; Primary UDI-DI: 04046964182037; Unit of Dose UDI-DI: 04046964182020. 2. Catalog Number: 354203; Primary UDI-DI: 04046964182051; Unit of Dose UDI-DI: 04046964182044.
Additional details
1. Catalog Number: 354202; Primary UDI-DI: 04046964182037; Unit of Dose UDI-DI: 04046964182020. 2. Catalog Number: 354203; Primary UDI-DI: 04046964182051; Unit of Dose UDI-DI: 04046964182044.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 2,871,707 units.
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