HIGH

B Braun Medical Recalls IV Administration Sets Over Backflow Risk

B Braun Medical recalled 19,104 IV administration sets on October 29, 2025. The recall stems from a potential for medication backflow and inability to prime. The affected sets were distributed worldwide, including the US 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 recalled IV administration sets include catalog number 490400, with primary UDI-DI 04046964761393 and unit of dose UDI-DI 04046964761386. These sets were sold globally, including distribution in Canada, Germany, Guatemala, and Singapore.

The Hazard

The recall addresses a significant safety concern. There is a potential for medication backflow from secondary IV containers into primary IV containers, which could compromise patient safety.

Reported Incidents

No specific incidents have been reported in connection with this recall. However, the high hazard level indicates a serious risk to patients.

What to Do

Stop using the IV administration sets immediately. Contact B Braun Medical Inc or your healthcare provider for further instructions. Follow the recall instructions provided in the notification letter.

Contact Information

For more information, contact B Braun Medical Inc at their website or customer service number. Additional details are available through the FDA recall notice.

Key Facts

  • Recalled product: IV Administration Sets
  • Catalog Number: 490400
  • Quantity: 19,104 units
  • Recall date: October 29, 2025
  • Hazard: Medication backflow risk

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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: 490400
Primary UDI-DI: 04046964761393
Unit of Dose UDI-DI: 04046964761386.
Report Date
December 3, 2025
Recall Status
ACTIVE

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