IV Administration Set utilized in gravity IV administration sets and pump administration sets uti...
FDA Recall #Z-0655-2026 — Class II — October 29, 2025
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 W/2 CARESITE & 2 ULTRAPORT ZERO; ULTRAPORT Zer0 IV Set with CARESITE; Catalog Number: 457504.
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
80,650 units
Distribution
Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
Code Information
1. Catalog Number: 457504; Primary UDI-DI: 04046964716089; Unit of Dose UDI-DI: 04046964716072.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated