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B Braun Medical Inc: Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume

Medical DevicesSource: FDA (device) · Date: 2025-12-03

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
B Braun Medical Inc
Product
Anesthesia IV 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. IV ADMIN SET, 2-HIGH FLOW STPCKS, 124 IN; Catalog Number: 490476.
Reason / hazard
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
Distribution / sold at
Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
Recall initiated
2025-10-29
Code info
Catalog Number: 490476; Primary UDI-DI: 04046964958953; Unit of Dose UDI-DI:04046964958946.
Product quantity
19,320 units
Voluntary mandated
Voluntary: Firm initiated
City
Bethlehem
State
PA
Country
United States
Event id
97816
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