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B Braun Medical Inc recalls IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus
Recalled December 3, 2025 · FDA recall Z-0677-2026 · B Braun Medical
Hazard
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). · FDA Class II
Units
5,952 units
Sold at
Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
Description
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Product
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. 15DR 2SAFELINE 1CARESITE 1STOPCOCK 131IN; Catalog Number: 490612.
Manufacturer(s)
B Braun Medical Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →