HIGH

B Braun Medical Recalls IV Administration Sets Due to Backflow Risk

B Braun Medical recalled 63,192 IV Administration Sets on October 29, 2025. The recall affects sets used with the Infusomat Space, Outlook, and Vista Basic Pumps. The company reported a risk of medication backflow and occlusion.

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 Administration Set is labeled with catalog number 490426. It has a primary UDI-DI of 04046964823503 and a unit of dose UDI-DI of 04046964823497. The sets were distributed worldwide, including the US, Canada, Germany, Guatemala, and Singapore.

The Hazard

The IV Administration Set poses a high risk due to potential backflow of medication from secondary IV containers into primary IV containers. This could lead to medication errors and ineffective treatment.

Reported Incidents

No specific incidents or injuries have been reported to date related to this recall. The potential for serious consequences from medication backflow necessitates immediate action.

What to Do

Stop using the recalled IV Administration Set immediately. Follow recall instructions provided by B Braun Medical Inc or contact your healthcare provider for further guidance.

Contact Information

For more information, contact B Braun Medical Inc. Visit their website or call for specific instructions regarding the recall.

Key Facts

  • 63,192 IV Administration Sets recalled
  • Risk of medication backflow and occlusion
  • Catalog number: 490426
  • Distribution in multiple countries
  • Immediate action required

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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: 490426
Primary UDI-DI: 04046964823503
Unit of Dose UDI-DI: 04046964823497
Expiration Date: Earliest Exp of Comp or 36mths.
Report Date
December 3, 2025
Recall Status
ACTIVE

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