HIGH

B Braun Medical Recalls Blood Administration Sets Over Backflow Risk

B Braun Medical recalled 24,624 blood administration sets on October 29, 2025, due to a risk of backflow from secondary IV containers. These sets are incompatible with the Infusomat Space, Outlook, and Vista Basic pumps. Healthcare providers must stop using these devices immediately to prevent potential medication errors.

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 with a 170 µm filter, catalog number 490355. It was distributed worldwide, including the US, Canada, Germany, Guatemala, and Singapore. These sets were sold under the brand B Braun Medical.

The Hazard

The blood administration sets may allow for backflow of medication from secondary IV containers into primary IV containers. This issue could result in medication errors and affect patient safety.

Reported Incidents

There are no specific reports of injuries or deaths linked to this recall. The potential for backflow presents a high risk of medication misadministration.

What to Do

Stop using the recalled blood administration sets immediately. Follow the recall instructions provided by B Braun Medical. Contact your healthcare provider or B Braun Medical Inc for further guidance.

Contact Information

For more information, contact B Braun Medical Inc. Visit their website or call their customer service line.

Key Facts

  • 24,624 units recalled
  • Risk of medication backflow
  • Stop using immediately
  • Global distribution including US

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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: 490355
Primary UDI-DI: 04046964616013
Unit of Dose UDI-DI: 04046964616006.
Report Date
December 3, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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