HIGH

B. Braun Medical Recalls 12,320 IV Burette Sets Over Backflow Risk (2025)

B. Braun Medical Inc. is recalling 12,320 burette sets worldwide used with Infusomat Space, Outlook Pump, and Vista Basic Pump. The device can allow backflow from secondary IV containers into primary containers and may fail to prime. Hospitals and clinics should stop using the device immediately and follow the recall 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

Burette sets are used to deliver precise volumes of IV medication in hospital settings. They are connected to gravity or pump-based IV systems to regulate dosing.

Why This Is Dangerous

Backflow can cause medication to move from secondary containers into primary ones, delivering incorrect dosages. Occlusion can prevent priming, disrupting IV therapy delivery.

Industry Context

This recall is not stated as part of a broader industry pattern.

Real-World Impact

Hospitals may need to halt certain IV delivery workflows. Replacement devices may be required to resume therapy without delay.

Practical Guidance

How to identify if yours is affected

  1. Check labeling on the burette set for Catalog Number 490252.
  2. Verify Primary UDI-DI 04046955545636 and Unit of Dose UDI-DI 04046955545629.
  3. Confirm it is used with Infusomat Space, Outlook Pump, or Vista Basic Pump.

Where to find product info

Identifiers are on the device label and packaging. Recall notices explain the affected lot or unit identifiers.

What timeline to expect

Recall notifications by letter are issued. Replacements or remediation guidance will follow from the manufacturer. Typical processing times may vary,

If the manufacturer is unresponsive

  • Document all contact attempts with the manufacturer.
  • Escalate to hospital risk management or C-suite leadership if needed.
  • File a report with the FDA if appropriate and required by hospital policy.

How to prevent similar issues

  • Use only manufacturer-approved burette sets with compatible pumps.
  • Check labels and UDIs before procurement.
  • Establish a recall-tracking process for infusion-related devices.

Documentation advice

Keep the recall letter, print or save the official recall page, take photos of labels, and log all correspondence with the manufacturer.

Product Details

Catalog Number: 490252; Primary UDI-DI: 04046955545636; Unit of Dose UDI-DI: 04046955545629; Quantity: 12,320 units; Distribution: Worldwide (US and international to Canada, Germany, Guatemala, and Singapore).

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 12,320 units recalled
  • Catalog Number: 490252
  • Primary UDI-DI: 04046955545636
  • Unit of Dose UDI-DI: 04046955545629
  • Hazard: backflow into primary IV containers and occlusion
  • Distribution: Worldwide (US, Canada, Germany, Guatemala, Singapore)

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: 490252
Primary UDI-DI: 04046955545636
Unit of Dose UDI-DI: 04046955545629
Report Date
December 3, 2025
Recall Status
ACTIVE

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