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
| 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
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 60 DROP W/2 CARESITE; Catalog Number: 354204. 2. Primary Gravity IV Set with 3 CARESITE¿ Injection Sites; IV ADMIN SET 15 DROP W/3 CARESITE; Catalog Number: 354205. 3. Primary Gravity IV Set with 3 CARESITE¿ Injection Sites; IV ADMIN SET 60 DROP W/3 CARESITE; Catalog Number: 354206.
Affected products
- Caresite utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista
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