HIGH

B Braun Medical Recalls IV Administration Sets Due to Backflow Risk

B Braun Medical recalled 3,120 IV administration sets on October 29, 2025, due to a risk of medication backflow. The recall affects models used with Infusomat Space, Outlook, and Vista Basic Pumps. The company advises patients and healthcare providers to stop using the devices immediately.

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 labeled as Catalog Number 490489. These devices were distributed globally, including the U.S., Canada, Germany, Guatemala, and Singapore. They are part of gravity IV administration sets and pump administration sets.

The Hazard

The recalled IV administration sets pose a high hazard of backflow from secondary IV containers into primary containers. This backflow can result in medication errors, potentially compromising patient safety.

Reported Incidents

As of the recall date, there have been no reported injuries or deaths associated with this defect. However, the potential for medication backflow necessitates immediate action.

What to Do

Stop using the IV administration sets immediately. Patients and healthcare providers should follow the recall instructions provided by B Braun Medical. Contact the manufacturer or your healthcare provider for further instructions.

Contact Information

For more information, contact B Braun Medical at 1-800-ABC-DEF0 or visit their website at www.bbraun.com.

Key Facts

  • 3,120 units recalled
  • Catalog Number: 490489
  • High hazard of backflow risk
  • Worldwide distribution
  • No injuries reported

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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: 490489
Primary UDI-DI: 04046955086894
Unit of Dose UDI-DI: 04046955086887.
Report Date
December 3, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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