HIGH

B Braun Medical Recalls Anesthesia IV Set Due to Backflow Risk

B Braun Medical recalled 104,784 Anesthesia IV Sets on October 29, 2025. The recall affects models utilized with Infusomat Space, Outlook, and Vista pumps due to potential medication backflow. This hazard poses serious risks for patients receiving IV medication.

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 affected products include IV ADMIN SET W/15 DROPS/ML, Catalog Number: 490469, and IV ADMIN SET, 60D 2 CARESITE VLV, Catalog Number: 490470. These sets were distributed worldwide, including the U.S., Canada, Germany, Guatemala, and Singapore.

The Hazard

The recalled Anesthesia IV Sets may allow medication backflow from secondary IV containers into primary containers, which can lead to incorrect dosing. The devices also have an occlusion issue, preventing proper priming.

Reported Incidents

No specific incident counts or injury numbers have been reported. The recall is classified as Class II, indicating a moderate risk.

What to Do

Healthcare providers and patients should stop using the recalled devices immediately. Follow the manufacturer's recall instructions and contact B Braun Medical Inc for further guidance.

Contact Information

For assistance, contact B Braun Medical Inc. Visit their website or call the number provided in the recall notification letter.

Key Facts

  • 104,784 units recalled
  • Potential high risk of medication backflow
  • Stop using devices immediately
  • Contact B Braun Medical for instructions

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Safety Assessment

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

Product Details

Model Numbers
1. Catalog Number: 490469
Primary UDI-DI: 04046964958816
Unit of Dose UDI-DI: 04046964958809. 2. Catalog Number: 490470
Primary UDI-DI: 04046964958830
Unit of Dose UDI-DI: 04046964958823.
Report Date
December 3, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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