HIGH

B Braun Medical Recalls IV Administration Sets Over Medication Backflow Risk

B Braun Medical recalled 1,080 IV administration sets on October 29, 2025. The recall affects sets used with the Infusomat Space, Outlook, and Vista Basic Pumps. The company identified a risk of backflow of medication from secondary IV containers into primary containers.

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 includes IV administration sets labeled with catalog number 490519. The sets were distributed worldwide, including the US, Canada, Germany, Guatemala, and Singapore.

The Hazard

The IV administration sets pose a high risk due to potential backflow of medication. This can result in contamination and incorrect dosages, posing serious health risks to patients.

Reported Incidents

No specific incidents or injuries have been reported as of the recall date. However, the potential for serious health implications necessitates immediate action.

What to Do

Patients and healthcare providers should stop using the recalled IV administration sets immediately. Contact B Braun Medical Inc or a healthcare provider for further instructions.

Contact Information

For more information, visit the FDA website at the provided URL or contact B Braun Medical Inc directly.

Key Facts

  • Catalog number 490519 included in the recall
  • 1,080 units distributed worldwide
  • High risk of medication backflow
  • Immediate cessation of use required
  • Contact manufacturer for instructions

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Safety Assessment

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

Product Details

Model Numbers
1. Catalog Number: 490519
Primary UDI-DI: 04046955185238
Unit of Dose UDI-DI: 04046955186549
Expiration Date: Earliest Exp of Comp or 36mths.
Report Date
December 3, 2025
Recall Status
ACTIVE

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