HIGH

B Braun Medical Recalls IV Administration Sets Over Backflow Risk

B Braun Medical recalled 98,568 IV administration sets on October 29, 2025. The recall affects sets labeled as Catalog Number 490274 due to a risk of medication backflow. Healthcare providers and patients should stop using these 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 recalled product is the IV Administration Set, Catalog Number 490274, used in gravity IV and pump administration systems. These sets were distributed worldwide, including the US, Canada, Germany, Guatemala, and Singapore.

The Hazard

The recall addresses a potential backflow of medication from secondary IV containers into primary containers. This issue can lead to medication errors and patient harm.

Reported Incidents

No specific incidents or injuries have been reported in connection with this recall. However, the nature of the hazard presents a high risk to patient safety.

What to Do

Patients and healthcare providers should immediately stop using the IV administration sets. Contact B Braun Medical Inc for further instructions and follow the recall instructions provided in the notification letter.

Contact Information

For more information, contact B Braun Medical Inc at [insert phone number if available] or visit their website at [insert website if available].

Key Facts

  • 98,568 units recalled
  • Catalog Number 490274
  • Risk of medication backflow
  • Stop using immediately
  • Contact B Braun Medical for instructions

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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: 490274
Primary UDI-DI: 04046964716621
Unit of Dose UDI-DI: 04046964716614
Expiration Date: Earliest Exp of Comp or 36mths.
Report Date
December 3, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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