HIGH

B. Braun Medical IV Extension Set Recall 2,100 Units Over Backflow Risk (2025)

B. Braun Medical Inc. recalled 2,100 IV Extension Sets used with Infusomat Space, Outlook and Vista Basic pumps sold worldwide to healthcare facilities. The extension set presents a backflow risk from secondary to primary IV containers and can hinder priming. Hospitals and clinicians should stop using the device immediately and follow the recall instructions provided by the manufacturer.

Quick Facts at a Glance

Recall Date
October 29, 2025
Hazard Level
HIGH
Brand
B. Braun Medical
Category
Health & Personal Care
Sold At
Multiple Retailers
At-Risk Groups
GENERAL

Hazard Information

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact B Braun Medical Inc or your healthcare provider for instructions. Notification method: Letter

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About This Product

An IV extension set connects a secondary IV bag to a primary set. It is used in hospitals to deliver medications or fluids. The recall targets a specific extension set used with gravity IV administration and pump systems.

Why This Is Dangerous

Backflow can cause medication to move from secondary to primary containers and can prevent priming, potentially leading to incorrect dosing or contamination.

Industry Context

This recall is not part of a broader industry pattern beyond IV administration accessories with backflow risks.

Real-World Impact

In healthcare settings, stopping use and following recall steps reduces patient risk of incorrect dosing and potential contamination.

Practical Guidance

How to identify if yours is affected

  1. Locate Catalog Number 456520 on the product or packaging
  2. Check Primary UDI-DI 04046964296697
  3. Check Unit of Dose UDI-DI 04046964296680

Where to find product info

Recall notification letter; FDA recall page; manufacturer website

What timeline to expect

Refunds or replacements typically processed within 4-8 weeks depending on institution

If the manufacturer is unresponsive

  • Escalate to hospital risk management or patient safety office
  • File a complaint with the FDA if manufacturers do not respond

How to prevent similar issues

  • Check packaging for catalog numbers before purchase
  • Ask distributors for certification of backflow protection in IV extension sets
  • Verify UDI codes during inventory management

Documentation advice

Retain recall letter, maintain correspondence with supplier, document affected lot numbers and inventory disposition

Product Details

Catalog Number: 456520 Primary UDI-DI: 04046964296697 Unit of Dose UDI-DI: 04046964296680 Sold worldwide; US distribution and international distribution to Canada, Germany, Guatemala, and Singapore Quantity: 2,100 units Recall Date: 2025-10-29 Status: Active Remedy: Stop using the device; contact B. Braun Medical Inc or your healthcare provider for instructions; notification by letter

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • Catalog Number: 456520
  • Primary UDI-DI: 04046964296697
  • Unit of Dose UDI-DI: 04046964296680
  • Quantity: 2,100 units
  • Global distribution: US, Canada, Germany, Guatemala, Singapore
  • Hazard: backflow between IV containers; occlusion risk
View Original Recall on FDA - Medical Devices

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Safety Guide

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeIV Extension Set
Sold At
Multiple Retailers

Product Details

Model Numbers
Catalog Number: 456520
Primary UDI-DI: 04046964296697
Unit of Dose UDI-DI: 04046964296680
Report Date
December 3, 2025
Recall Status
ACTIVE

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