HIGH

B Braun Medical Recalls Blood Administration Set Over Backflow Risk

B Braun Medical recalled 33,528 blood administration sets on October 29, 2025. The recall affects sets used with Infusomat Space, Outlook, and Vista Basic Pumps. The devices pose a backflow risk that could compromise patient safety.

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 product is the Y-Type Blood Set, catalog number 490530. The devices were distributed worldwide, including the United States, Canada, Germany, Guatemala, and Singapore. The sets were sold as part of gravity IV administration sets and pump administration sets.

The Hazard

The recall stems from a potential backflow of medication from secondary IV containers into primary containers. This condition can lead to medication errors and serious health risks for patients.

Reported Incidents

Currently, there are no reported incidents or injuries associated with the recalled blood administration sets. However, the potential risks necessitate immediate action.

What to Do

Healthcare providers and patients should stop using the blood administration sets immediately. Follow the recall instructions provided by B Braun Medical Inc. Contact your healthcare provider for further instructions.

Contact Information

For questions, contact B Braun Medical Inc. at their customer service line or visit their website for additional information.

Key Facts

  • Recall date: October 29, 2025
  • Quantity recalled: 33,528 units
  • Risk of backflow from secondary IV containers
  • Distribution includes US, Canada, Germany, Guatemala, Singapore

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Safety Assessment

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

Product Classification

Product TypeBlood Administration Set
Sold At
Multiple Retailers

Product Details

Model Numbers
Catalog Number: 490530
Primary UDI-DI: 04046955203321
Unit of Dose UDI-DI: 04046955203314.
Report Date
December 3, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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