HIGH

B Braun Medical Recalls IV Extension Sets Over Medication Backflow Risk

B Braun Medical recalled 27,480 IV extension sets on October 29, 2025. The recall affects devices tied to the Infusomat Space, Outlook, and Vista pumps. The company warns of potential medication backflow and occlusion issues that could endanger 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 includes IV extension sets labeled as EXT SET ULTRAPORT STOPCOCK, 37IN., Catalog Number: 490234. These products distributed worldwide include the U.S., Canada, Germany, Guatemala, and Singapore.

The Hazard

The recalled extension sets pose a high risk of backflow of medication from secondary IV containers into primary containers. This condition can lead to incorrect medication dosing and potential patient harm.

Reported Incidents

There are no specific reported injuries or deaths associated with this recall at this time. The potential for serious adverse effects due to medication backflow raises significant safety concerns.

What to Do

Patients and healthcare providers should stop using these IV extension sets immediately. Contact B Braun Medical Inc or your healthcare provider for further instructions on the recall.

Contact Information

For more information, call B Braun Medical Inc. at 1-800-227-2862 or visit their website at www.bbraun.com.

Key Facts

  • Recalled product: IV extension set, Catalog Number: 490234
  • Total units recalled: 27,480
  • Hazard: Medication backflow risk
  • Stop using the product immediately
  • Contact B Braun Medical for recall instructions

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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: 490234
Primary UDI-DI: 04046964716362
Unit of Dose UDI-DI: 04046964716355.
Report Date
December 3, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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