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Recall Category: Medical Device Recalls
Recalling Firm: B Braun Medical Inc
Product: 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.
Reason for Recall: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Classification: Class II
Status: Ongoing
Report Date: 12/03/2025
Recall Initiation Date: 10/29/2025
Distribution: Worldwide distribution – US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
Code Info: Catalog Number: 490355; Primary UDI-DI: 04046964616013; Unit of Dose UDI-DI: 04046964616006.
Product Quantity: 24,624 units
Recall Type: Voluntary: Firm initiated
Initial Firm Notification: Letter
Firm Location: Bethlehem, PA, United States
Recall Number: Z-0617-2026
Event ID: 97816