HIGH

B Braun Medical Recalls IV Extension Set Over Medication Backflow Risk

B Braun Medical recalled 32,500 IV extension sets on October 29, 2025. The recall stems from a risk of medication backflow from secondary IV containers. Patients and healthcare providers must stop using the devices immediately.

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 involves the Caresite Extension Set, Catalog Number 470183. These sets were distributed worldwide, including the US, Canada, Germany, Guatemala, and Singapore. No retail price was provided.

The Hazard

The extension set poses a risk of medication backflow from secondary IV containers to primary IV containers. This can potentially lead to dosing errors and adverse patient outcomes.

Reported Incidents

No specific incidents or injuries have been reported. The recall is classified as Class II, indicating a potential for serious health issues.

What to Do

Stop using the recalled IV extension sets immediately. Follow the manufacturer's recall instructions and contact B Braun Medical or your healthcare provider for further guidance.

Contact Information

For assistance, reach B Braun Medical Inc at their official website or contact your healthcare provider.

Key Facts

  • Recall date: October 29, 2025
  • Quantity: 32,500 units
  • Distributed worldwide including the US and Canada
  • Class II recall due to hazardous conditions

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Safety Assessment

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

Product Classification

Product TypeIV Administration Set
Sold At
Multiple Retailers

Product Details

Model Numbers
1. Catalog Number: 470183
Primary UDI-DI: 04046964719400
Unit of Dose UDI-DI: 04046964715549.
Report Date
December 3, 2025
Recall Status
ACTIVE

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