Medical Device Recall: 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 th
B Braun Medical Inc · October 29, 2025
Reason for Recall
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.
Distribution
Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
Quantity Affected
135,000 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0651-2026
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.