HIGH

B Braun Medical Recalls IV Administration Sets Over Backflow Risk

B Braun Medical recalled 41,016 IV administration sets on October 29, 2025. The recall addresses the risk of medication backflow into primary IV containers. This issue could lead to significant health risks for patients receiving intravenous therapy.

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 IV Administration Sets with catalog numbers 490522 and 490568. These products were distributed worldwide, including the US, Canada, Germany, Guatemala, and Singapore. They were sold for an unspecified price.

The Hazard

The recalled IV administration sets pose a high risk due to potential backflow of medication from secondary IV containers into primary IV containers. This can lead to serious medication errors and compromise patient safety.

Reported Incidents

No specific incidents were reported in the recall notice. However, the potential for serious health risks exists due to the nature of the hazard.

What to Do

Stop using the recalled IV administration sets immediately. Follow the instructions provided by B Braun Medical for returning the product and obtaining further assistance.

Contact Information

For more information, contact B Braun Medical Inc. at their customer service number or visit their website for additional guidance.

Key Facts

  • 41,016 units recalled
  • Catalog Numbers: 490522, 490568
  • Risk of medication backflow
  • Worldwide distribution

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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: 490522
Primary UDI-DI: 04046955203123
Unit of Dose UDI-DI: 04046955203116
Expiration Date: Earliest Exp of Comp or 36mths. 2. Catalog Number: 490568
Primary UDI-DI: 04046955275663
+2 more
Report Date
December 3, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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