HIGH

B Braun Medical Recalls 98,568 IV Administration Sets for Backflow and Occlusion Risk (2025)

B Braun Medical recalled 98,568 IV administration sets used with Infusomat Space, Outlook, and Vista Basic pumps. The recall covers catalog number 490274 and UDI-DI codes. The device presents a backflow risk and inability to prime. Hospitals and patients should stop using the device immediately and follow the manufacturer’s 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 are sterile tubing systems used to deliver fluids and medications intravenously. They are used with gravity or pump-based infusion systems in hospitals.

Why This Is Dangerous

Backflow from secondary to primary IV containers can lead to improper dosing. Inability to prime can prevent proper delivery and introduce contamination risk.

Industry Context

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

Real-World Impact

The issue can disrupt critical medication delivery and require hospital procurement teams to replace affected lots, potentially affecting patient care and workflow.

Practical Guidance

How to identify if yours is affected

  1. Check Catalog Number 490274 on packaging
  2. Verify Primary UDI-DI 04046964716621
  3. Verify Unit of Dose UDI-DI 04046964716614
  4. Note Expiration: Earliest expiry of component or 36 months

Where to find product info

Packaging labeling, FDA recall page, and manufacturer communications

What timeline to expect

Recall process and replacements typically follow hospital procurement timelines; expected 4-8 weeks for resolution

If the manufacturer is unresponsive

  • Escalate to hospital risk management
  • File a complaint with the CPSC if applicable
  • Seek guidance directly from B Braun Medical for instructions
  • Consult your institution’s procurement for alternatives

How to prevent similar issues

  • Verify device labeling before use
  • Ensure priming protocols are followed for IV sets
  • Maintain up-to-date recall monitoring from FDA/ manufacturer
  • Use IV sets with proven backflow prevention features when available

Documentation advice

Keep a copy of recall notices, record recall number Z-0698-2026, save correspondences with the manufacturer, photograph packaging and labeling

Product Details

Model numbers: Catalog Number 490274. Primary UDI-DI 04046964716621. Unit of Dose UDI-DI 04046964716614. Expiration: Earliest Exp of Component or 36 months. Sold worldwide with US distribution and international distribution to Canada, Germany, Guatemala, and Singapore. Quantity recalled: 98,568 units. Price: Unknown. Sold/distribution: Worldwide.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 98,568 units recalled
  • Catalog Number 490274
  • Primary UDI-DI 04046964716621
  • Unit of Dose UDI-DI 04046964716614
  • Worldwide distribution to US, Canada, Germany, Guatemala, Singapore
  • Earliest expiry date per component or 36 months

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 Classification

Product Details

Model Numbers
490274
04046964716621
04046964716614
Report Date
December 3, 2025
Recall Status
ACTIVE

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