HIGH

B Braun Medical Recalls IV Extension Sets Over Backflow Risk

B Braun Medical recalled 11,650 IV extension sets on October 29, 2025, due to potential backflow of medication. This defect affects the Infusomat Space, Outlook, and Vista Basic Pumps. Patients must stop using the device immediately and follow 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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Product Details

The recalled IV extension sets are labeled with catalog number AS152V2DLL and primary UDI-DI 04046964299636. These devices were distributed worldwide, including the United States, Canada, Germany, Guatemala, and Singapore. They were sold in quantities totaling 11,650 units.

The Hazard

The IV extension sets may allow backflow of medication from secondary IV containers into primary containers. This situation could lead to incorrect medication dosages and potential harm to patients.

Reported Incidents

As of now, there are no reported injuries or deaths associated with this recall. However, the potential for serious medication errors poses a significant risk.

What to Do

Patients and healthcare providers should stop using the recalled IV extension sets immediately. Contact B Braun Medical or your healthcare provider for further instructions and to discuss the recall process.

Contact Information

For more information, call B Braun Medical at 1-800-xxx-xxxx or visit their website at www.bbraun.com.

Key Facts

  • Recall date: October 29, 2025
  • Quantity recalled: 11,650 units
  • Affected models: Catalog Number AS152V2DLL
  • Distribution: Worldwide, including the US
  • Hazard: Potential backflow of medication

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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: 473309
Primary UDI-DI: 04046964299636
Unit of Dose UDI-DI: 04046964299629.
Report Date
December 3, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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