HIGH

B. Braun Medical Blood Administration Set Recall 7,344 Units Over Backflow Risk (2025)

B. Braun Medical recalled 7,344 Blood Administration Sets used with Infusomat Space, Outlook Pump, and Vista Basic Pump. The devices may allow backflow from secondary (piggyback) IV containers into primary IV containers and cannot be primed. Hospitals and healthcare providers should stop using the devices immediately and follow manufacturer instructions.

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

Blood administration sets are used to deliver blood products via gravity or pumped IV systems. They connect to IV bags or containers and are used in hospital settings for transfusions.

Why This Is Dangerous

A backflow risk means medication could flow backwards from a secondary container into the primary line, potentially altering dosage. An occlusion can prevent proper priming and flow.

Industry Context

This recall is not described as part of a broader industry pattern in the provided data.

Real-World Impact

The recall could disrupt transfusion workflows and delay treatment in hospitals if affected sets remain in use.

Practical Guidance

How to identify if yours is affected

  1. 1) Locate Catalog Number 490196 on the packaging
  2. 2) Confirm Primary UDI-DI 04046964303722
  3. 3) Confirm Unit of Dose UDI-DI 04046964303715
  4. 4) Verify usage with Infusomat Space, Outlook, or Vista Basic Pumps

Where to find product info

Recall notices and instructions are available on the FDA enforcement page linked in the notice

What timeline to expect

Processing times for replacement or remedy are not specified; hospitals should coordinate with BBraun Medical and suppliers

If the manufacturer is unresponsive

  • Document all communications
  • Escalate to hospital procurement or risk management
  • File a complaint with FDA if manufacturer or distributor is unresponsive

How to prevent similar issues

  • Verify catalog numbers and UDIs before selecting IV sets
  • Maintain a supplier audit for high-risk medical devices
  • Keep recall and safety notices accessible to procurement staff

Documentation advice

Keep copy of the recall notice, model numbers, UDIs, purchase records, and all communications with the manufacturer and suppliers

Product Details

Catalog Number: 490196. Primary UDI-DI: 04046964303722. Unit of Dose UDI-DI: 04046964303715. Sold worldwide, including US, Canada, Germany, Guatemala, and Singapore. Product description: Y-TYPE BLOOD SET 124 IN. Distribution: Worldwide distribution.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 7,344 units recalled
  • Catalog Number 490196
  • Primary UDI-DI 04046964303722
  • Unit of Dose UDI-DI 04046964303715
  • Worldwide distribution including US, Canada, Germany, Guatemala, Singapore
  • Hazard: backflow and occlusion risk; backflow from secondary to primary IV containers

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

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

Product Details

Model Numbers
Catalog Number: 490196
Primary UDI-DI: 04046964303722
Unit of Dose UDI-DI: 04046964303715
Report Date
December 3, 2025
Recall Status
ACTIVE

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