B Braun Medical Inc

Devices recall · Z-0617-2026

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

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 W/ 170 ?M FILTER 120 IN; Catalog Number: 490355.

Recalling firm

B Braun Medical Inc

Product quantity

24,624 units

Lot / code info

Catalog Number: 490355; Primary UDI-DI: 04046964616013; Unit of Dose UDI-DI: 04046964616006.

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