HIGH

B. Braun Medical IV Administration Set Recalled for Backflow and Occlusion Risk (2025)

B Braun Medical Inc recalled 1,019 IV administration sets worldwide after reports of backflow and occlusion. The devices were used with BBMI Infusomat Space, Outlook, and Vista Basic pumps. The recall affects a single catalog number 457506 with UDI details. Patients should stop using the device and follow manufacturer instructions for return.

Quick Facts at a Glance

Recall Date
October 29, 2025
Hazard Level
HIGH
Brand
BBraun Medical
Category
Health & Personal Care
Sold At
Unknown
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

IV administration sets enable IV drug delivery via gravity or pump systems. They connect the IV bag to the patient and may include piggyback configurations.

Why This Is Dangerous

Backflow from secondary to primary IV containers can lead to unintended dosing and contamination. Occlusion prevents proper priming of the line.

Industry Context

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

Real-World Impact

High risk to patients if backflow occurs or priming fails, potential for incorrect dosing or interrupted therapy.

Practical Guidance

How to identify if yours is affected

  1. Locate Catalog Number 457506 on the IV set package or device.
  2. Verify UDI-DI 04046964716126 (Primary) and 04046964716119 (Unit of Dose).
  3. Confirm BBMI Infusomat Space, Outlook, or Vista Basic pump usage.

Where to find product info

UDI and catalog numbers are on labeling; contact manufacturer for recall specifics.

What timeline to expect

The recall was announced by FDA enforcement with notice dated 2025-12-03; timelines for refunds or replacements are per manufacturer instructions.

If the manufacturer is unresponsive

  • Document all contact attempts
  • Escalate to manufacturer and FDA if needed
  • Consider file a complaint with consumer protection if delays occur

How to prevent similar issues

  • Verify device compatibility before use with BBMI pumps
  • Use only approved IV sets from the same manufacturer
  • Maintain updated recall watchlist for IV supplies

Documentation advice

Keep recall letter, packaging, device labeling, and all correspondence with manufacturer.

Product Details

Catalog Number: 457506. Primary UDI-DI: 04046964716126. Unit of Dose UDI-DI: 04046964716119. Sold worldwide including US, Canada, Germany, Guatemala, Singapore. Quantity: 1,019 units. Brand: B Braun Medical Inc. Related pumps: BBMI Infusomat Space Large Volume Pump, Outlook Pump, Vista Basic Pump.

Reported Incidents

No injuries or incidents have been reported in the document provided.

Key Facts

  • 1,019 units recalled
  • Catalog Number 457506
  • Primary UDI-DI 04046964716126
  • Unit of Dose UDI-DI 04046964716119
  • Worldwide distribution including US, Canada, Germany, Guatemala, Singapore
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
ELECTRICALOTHER

Product Classification

Product TypeIV Administration Set
Sold At
Unknown

Product Details

Model Numbers
Catalog Number: 457506
Primary UDI-DI: 04046964716126
Unit of Dose UDI-DI: 04046964716119
Report Date
December 3, 2025
Recall Status
ACTIVE

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