HIGH

B. Braun Medical Rate Flow IV Set Recalled for 150,664 Units in 2025

B. Braun Medical recalled 150,664 Rate Flow IV Sets used with Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump. The devices are cataloged as 375258. The recall addresses a potential backflow from piggyback IV containers into primary containers and an inability to prime. Hospitals and healthcare providers should stop using the device immediately and follow the manufacturer’s rec

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

Rate Flow IV Sets are used to deliver intravenous solutions either by gravity or through infusion pumps in healthcare settings. They connect to IV containers and allow controlled flow into patients.

Why This Is Dangerous

Backflow from secondary to primary IV containers may occur, risking unintended dosing or contamination. Inability to prime increases risk of under-infusion or occlusion.

Industry Context

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

Real-World Impact

Hospitals and clinics may need to replace affected sets promptly to prevent potential medication backflow and priming failures, affecting patient care operations and budgets.

Practical Guidance

How to identify if yours is affected

  1. Check Catalog Number 375258 on the device packaging or label.
  2. Verify Primary UDI-DI 04046955256976 and Unit of Dose UDI-DI 04046955256969.
  3. Confirm expiration based on the component expiry or 36 months from manufacture.

Where to find product info

UDI-DI and catalog numbers are typically printed on the tubing set packaging and on the device label.

What timeline to expect

Refunds or replacements are typically processed within 4-6 weeks after verification.

If the manufacturer is unresponsive

  • Document all communications with the supplier.
  • Escalate to hospital risk management or contact FDA if the supplier is unresponsive.

How to prevent similar issues

  • Verify all IV sets against current recalls before use.
  • Keep an updated inventory of IV sets and their lot/UDI numbers.
  • Require backflow-prevention features where possible.

Documentation advice

Keep the recall notice, supplier correspondence, and replacement records. Photograph catalog numbers and UDIs for proof.

Product Details

Catalog Number: 375258; Primary UDI-DI: 04046955256976; Unit of Dose UDI-DI: 04046955256969; Expiration Date: Earliest Exp of Component or 36 months; Distribution: Worldwide, including US, Canada, Germany, Guatemala, Singapore; Quantity: 150,664 units; Sold distribution: Worldwide to hospitals and healthcare facilities.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • Catalog Number 375258
  • Primary UDI-DI 04046955256976
  • Unit of Dose UDI-DI 04046955256969
  • Distribution: Worldwide; US, Canada, Germany, Guatemala, Singapore
  • Quantity: 150,664 units
  • Recall date: 2025-10-29

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
7/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
Catalog Number: 375258
Primary UDI-DI: 04046955256976
Unit of Dose UDI-DI: 04046955256969
Report Date
December 3, 2025
Recall Status
ACTIVE

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