HIGH

B Braun Medical Recalls 12,200 IV Administration Sets for Backflow and Occlusion Risk (2025)

B Braun Medical recalls 12,200 IV administration sets sold to hospitals and medical distributors worldwide. The devices labeled NF1503 and catalog number 490062 may allow backflow of medication from secondary piggyback IV containers into primaries and may fail to prime. Hospitals should stop using the devices 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

IV administration sets deliver IV fluids from a primary container to a patient. They connect to pumps or gravity systems in hospitals.

Why This Is Dangerous

Backflow can cause medication to flow into the wrong container. Inability to prime can result in under- or incorrect dosing.

Industry Context

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

Real-World Impact

Hospitals must halt use of affected sets to avoid dosing errors. The impact is operational disruption and potential patient safety risk if backflow occurs.

Practical Guidance

How to identify if yours is affected

  1. Check packaging for NF1503 label and Catalog Number 490062.
  2. Verify Primary UDI-DI 04046964301445 and Unit of Dose UDI-DI 04046964301438.
  3. Confirm expiration date is within the listed constraints.

Where to find product info

Look at product packaging, instruction sheets, and the recall page (FDA listing) for UDI and catalog numbers.

What timeline to expect

No processing timeline is provided. Replacements or refunds may follow manufacturer guidance and hospital procurement processes.

If the manufacturer is unresponsive

  • Document all outreach attempts to the manufacturer.
  • Escalate to hospital compliance or risk management.
  • If needed, contact the FDA’s recall program for guidance.

How to prevent similar issues

  • Vet new lots against the recall before acceptance.
  • Use only sets with current recall status.
  • Verify UDI-DI codes prior to use in any patient care setting.

Documentation advice

Keep the recall notice, lot numbers, and correspondence. Photograph labeling and packaging for records.

Product Details

Catalog Number: 490062; Primary UDI-DI: 04046964301445; Unit of Dose UDI-DI: 04046964301438; Expiration Date: Earliest Exp of Component or 60 months; Sold worldwide with US distribution and international distribution to Canada, Germany, Guatemala, and Singapore; Quantity: 12,200 units; Model identifiers include NF1503 15 DR UNIV SPIKE, INJ SITE, BCV.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 12,200 units recalled
  • Global distribution includes US, Canada, Germany, Guatemala, Singapore
  • Catalog Number 490062 and NF1503 15 DR UNIV SPIKE
  • UDI-DI numbers: 04046964301445 and 04046964301438

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
490062
NF1503 15 DR UNIV SPIKE, INJ SITE, BCV
Report Date
December 3, 2025
Recall Status
ACTIVE

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