← FDA ENFORCEMENT
Z-0628-2026Class II

B Braun Medical Inc

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
B Braun Medical Inc
Product type
Device
Status
Ongoing
Report date
2025-12-03
Distribution
Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
Firm state
PA
Product quantity
30,250 units
Initiated by
Voluntary: Firm initiated
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

Extension 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. ET08US EXTENSION SET W/ULTRA Y SITE; Catalog Number: 474912.

Code / lot info

1. Catalog Number: 474912; Primary UDI-DI: 04046964300615; Unit of Dose UDI-DI: 04046964300608.

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →