HIGH

B Braun Medical Recalls IV Administration Set Over Backflow Risk

B Braun Medical recalled 5,100 IV administration sets on October 29, 2025. The recall affects devices used with Infusomat Space, Outlook, and Vista Basic Pumps. The product poses a high risk of medication backflow from secondary IV 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 is labeled as IV ADMIN SET 103 IN., Catalog Number: 490239. It was distributed worldwide, including the U.S., Canada, Germany, Guatemala, and Singapore.

The Hazard

The IV administration set may allow backflow of medication from secondary IV containers into primary IV containers. This malfunction could compromise patient safety.

Reported Incidents

There are no specific reported incidents of injury or death associated with this recall. However, the potential for medication backflow poses significant health risks.

What to Do

Stop using the IV administration set immediately. Follow the recall instructions provided by B Braun Medical. Contact your healthcare provider for further guidance.

Contact Information

For more information, contact B Braun Medical Inc. Visit the FDA recall page for further details at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0699-2026.

Key Facts

  • Recalled product: IV administration set, Catalog Number: 490239
  • 5,100 units recalled
  • Used with Infusomat Space, Outlook, and Vista Basic Pumps
  • Risk of backflow of medication
  • No injuries or deaths reported

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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: 490239
Primary UDI-DI: 04046964716423
Unit of Dose UDI-DI: 04046964716416
Expiration Date: Earliest Exp of Comp or 24mths.
Report Date
December 3, 2025
Recall Status
ACTIVE

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