HIGH

B Braun Medical Recalls IV Administration Sets Over Backflow Risk

B Braun Medical recalled 4,488 IV administration sets on October 29, 2025. The recall follows reports of potential backflow of medication from secondary IV containers. This issue may affect patient safety and requires immediate action from healthcare providers and patients.

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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Product Details

The recall involves IV administration sets used with B Braun's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. The affected catalog number is 490551. These products were distributed worldwide, including the US, Canada, Germany, Guatemala, and Singapore.

The Hazard

The IV administration sets pose a risk of medication backflow from secondary to primary IV containers. This can lead to incorrect dosages and potential patient harm.

Reported Incidents

As of the report date, no specific injuries or deaths have been documented. The risk level is classified as high due to the potential for serious health consequences.

What to Do

Patients and healthcare providers should stop using the affected IV administration sets immediately. Follow the recall instructions provided by the manufacturer and contact B Braun Medical Inc for further guidance.

Contact Information

For more information, contact B Braun Medical Inc at their customer service number or visit their website.

Key Facts

  • 4,488 units recalled
  • Catalog Number: 490551
  • Risk of medication backflow
  • Class II recall
  • Worldwide distribution

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeIV Administration Set
Sold At
Multiple Retailers

Product Details

Model Numbers
1. Catalog Number: 490551
Primary UDI-DI: 04046955275304
Unit of Dose UDI-DI: 04046955275298
Expiration Date: Earliest Exp of Comp or 36mths.
Report Date
December 3, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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