Serious health risk
⚠ This recall is currently active
B Braun Medical Inc
Devices recall · Z-0656-2026
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 ADMIN SET W/15 DROPS/ML 126 IN; Catalog Number: 490283.
Recalling firm
B Braun Medical Inc
Product quantity
65,904 units
Lot / code info
1. Catalog Number: 490283; Primary UDI-DI: 04046964716669; Unit of Dose UDI-DI: 04046964716652.
Distribution
Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
Recall initiated
2025-10-29
Status
Ongoing
Location
Bethlehem, PA, United States
Voluntary / mandated
Voluntary: Firm initiated
Initial notification
Letter
Data from official federal safety records. Updated periodically. Verify on FDA.gov