Home / Recalls / B Braun Medical Inc / Z-0626-2026

Z-0626-2026 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
381,850 units

Product Description

Caresite 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. Primary Gravity Filtered Set with 2 CARESITE¿ Injection Sites; IV ADM 15 DROP W/2 CARESITE FILTER; Catalog Number: 354207.

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

1. Catalog Number: 354207; Primary UDI-DI: 04046964182136; Unit of Dose UDI-DI: 04046964182129.

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