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B Braun Medical Inc recalls ADDitIV utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Lar
Recalled December 3, 2025 · FDA recall Z-0605-2026 · 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
12,700 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
ADDitIV 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. PB602VSL NON-VENT SET 103-IN-DR; Catalog Number: 352062.
Manufacturer(s)
B Braun Medical Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →