HIGH

B Braun Medical Recalls IV Administration Sets Over Backflow Risk

B Braun Medical recalled 150,664 IV administration sets on October 29, 2025. The recall affects products identified by catalog number 375258. These devices pose a high risk of medication backflow from secondary IV containers.

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 recalled product includes RATE FLOW sets used in gravity IV and pump administration with catalog number 375258. These sets were distributed worldwide, including the United States, Canada, Germany, Guatemala, and Singapore.

The Hazard

The recall involves a potential for backflow of medication from secondary piggyback IV containers into primary IV containers. This defect can lead to improper dosing and potential harm to patients.

Reported Incidents

No specific incidents have been reported at this time, but the potential risks associated with backflow could result in serious health complications.

What to Do

Stop using the device immediately. Follow the manufacturer's recall instructions and contact B Braun Medical Inc or your healthcare provider for further information.

Contact Information

For more information, call B Braun Medical at the contact number provided in the recall notification or visit their website.

Key Facts

  • Recall date: October 29, 2025
  • Catalog number: 375258
  • Worldwide distribution including US, Canada, Germany, Guatemala, Singapore
  • High hazard level identified

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Safety Assessment

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

Product Classification

Product Details

Model Numbers
1. Catalog Number: 375258
Primary UDI-DI: 04046955256976
Unit of Dose UDI-DI: 04046955256969
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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