HIGH

B Braun Medical Recalls IV Administration Sets Due to Backflow Risk

B Braun Medical recalled 187,464 IV administration sets on October 29, 2025. The recall stems from the potential for medication backflow and occlusion. The affected products were distributed worldwide, including the U.S. and Canada.

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 affects the following catalog numbers: 490488 (126 in.), 490492 (132 in.), and 490503 (139 in.). These sets are used with B Braun Medical's Infusomat Space, Outlook, and Vista Basic Pumps. The products were sold globally.

The Hazard

The recalled IV administration sets pose a risk of backflow of medication from secondary IV containers into primary containers. This can lead to medication errors and patient harm.

Reported Incidents

The recall was classified as Class II, indicating a high hazard level. There have been no specific incidents or injuries reported to date.

What to Do

Patients and healthcare providers must stop using the affected IV administration sets immediately. Follow the recall instructions provided by B Braun Medical or contact your healthcare provider.

Contact Information

For more information, contact B Braun Medical at 1-800-xxx-xxxx or visit their website at www.bbraun.com.

Key Facts

  • Recall date: October 29, 2025
  • Active recall status
  • Worldwide distribution
  • Class II recall classification

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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: 490488
Primary UDI-DI: 04046955086870
Unit of Dose UDI-DI: 04046955086863
Expiration Date: Earliest Exp of Comp or 24mths. 2. Catalog Number: 490492
Primary UDI-DI: 04046955086757
+5 more
Report Date
December 3, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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