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. IV SET 3 CARESITE ULTRA ZERO 2/SWAB SAFE; IV Se
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | October 29, 2025 |
| Reported | December 03, 2025 |
| Recalling firm | B Braun Medical Inc |
| Country / region | United States PA |
Hazard
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Product description
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. IV SET 3 CARESITE ULTRA ZERO 2/SWAB SAFE; IV Set With 3 CARESITE Injection Sites, ULTRAPORT Zer0 High-Flow, 4-Way Stopcock, and Dual Port SAFEPORT; Catalog Number: 457515.
Affected products
- IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pu
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