HIGH

B Braun Medical Recalls IV Administration Set Over Backflow Risk

B Braun Medical recalled 286,400 IV administration sets on October 29, 2025. The recall follows reports of potential backflow of medication from secondary IV containers into primary IV containers. Users must stop using the devices immediately and follow the manufacturer's instructions.

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 IV Administration Set, catalog number 354211. It was distributed worldwide, including the US, Canada, Germany, Guatemala, and Singapore. The sets were sold for an undisclosed price.

The Hazard

The IV administration set poses a high hazard risk due to the potential for backflow of medication from secondary IV containers into primary IV containers. This backflow can lead to incorrect dosing or contamination.

Reported Incidents

No specific incidents of injury or death have been reported. The recall is classified as Class II, indicating a risk of serious injury.

What to Do

Stop using the IV administration set immediately. Contact B Braun Medical Inc or your healthcare provider for further instructions and to follow the recall process.

Contact Information

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

Key Facts

  • Recalled product: IV Administration Set, Catalog Number 354211
  • Quantity recalled: 286,400 units
  • Risk of medication backflow
  • Stop use immediately
  • Contact manufacturer for instructions

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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: 354211
Primary UDI-DI: 04046964182198
Unit of Dose UDI-DI: 04046964182181
Expiration Date: Earliest Exp of Comp or 24mths.
Report Date
December 3, 2025
Recall Status
ACTIVE

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