HIGH

B Braun Medical Recalls Blood Administration Sets Over Backflow Risk

B Braun Medical recalled 5,448 blood administration sets on October 29, 2025. The recall affects devices used with Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. The company cited potential backflow of medication and occlusion as the primary hazards.

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 170µm filter, catalog number 480233. The blood administration sets were distributed worldwide, including the US, Canada, Germany, Guatemala, and Singapore. They are part of the B Braun Medical's line of IV administration sets.

The Hazard

The blood administration sets pose a high risk due to the potential for backflow of medication from secondary IV containers into primary containers, which could lead to medication errors. Additionally, users may experience occlusion, making it difficult to prime the device.

Reported Incidents

As of now, there have been no reported injuries or deaths associated with this recall. The company initiated the recall as a precautionary measure after identifying the potential hazards.

What to Do

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

Contact Information

For further details, contact B Braun Medical Inc. at 1-800-288-2370 or visit their website at www.bbraun.com.

Key Facts

  • Recall date: October 29, 2025
  • Total units recalled: 5,448
  • Catalog number: 480233
  • Affected models include Infusomat Space, Outlook, Vista pumps
  • Hazard classification: Class II

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Safety Assessment

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

Product Classification

Product Details

Model Numbers
Catalog Number: 480233
Primary UDI-DI: 04046955083572
Unit of Dose UDI-DI: 04046955083565.
Report Date
December 3, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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