B.BRAUN utilized in gravity IV administration sets and pump administration sets utilized with BBM...
FDA Recall #Z-0615-2026 — Class II — October 29, 2025
Product Description
B.BRAUN 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/ 60 DROPS/ML,141 in.; Catalog Number: 490349.
Reason for Recall
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Recalling Firm
B Braun Medical Inc — Bethlehem, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
24,648 units
Distribution
Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
Code Information
Catalog Number: 490349; Primary UDI-DI: 04046964602405; Unit of Dose UDI-DI: 04046964602399.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated