Medical Device Recall: Blood 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
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
Blood 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. Y-TYPE BLOOD SET, HAND PUMP, 146 IN.; Catalog Number: 490438.
Distribution
Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
Quantity Affected
164,568 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0619-2026
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.