Home / Recalls / B Braun Medical Inc / Z-0619-2026

Z-0619-2026 Class II Ongoing

Recalled by B Braun Medical Inc — Bethlehem, PA

Recall Details

Product Type
Devices
Report Date
December 3, 2025
Initiation Date
October 29, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
164,568 units

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.

Reason for Recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Distribution Pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

Code Information

Catalog Number: 490438; Primary UDI-DI: 04046964833441; Unit of Dose UDI-DI: 04046964833434.

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