HIGH

B Braun Medical Recalls Anesthesia IV Set Due to Backflow Risk

B Braun Medical recalled 10,536 Anesthesia IV Sets on October 29, 2025. The recall stems from a risk of medication backflow between IV containers. Healthcare providers must stop using the product immediately to prevent potential harm.

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 Anesthesia IV Set is catalog number 490472 and has a primary UDI-DI of 04046964958878. The product was distributed worldwide, including the US, Canada, Germany, Guatemala, and Singapore.

The Hazard

The Anesthesia IV Set poses a high risk of backflow of medication from secondary IV containers into primary IV containers. This defect could lead to incorrect medication dosing and potential patient harm.

Reported Incidents

As of the recall date, there are no reported injuries or deaths associated with this product. However, the risk of medication errors remains a serious concern.

What to Do

Stop using the Anesthesia IV Set immediately. Follow the recall instructions provided by B Braun Medical Inc. Contact your healthcare provider for guidance.

Contact Information

For further information, contact B Braun Medical Inc. or visit their website. Recall notifications are being sent via letter.

Key Facts

  • Catalog Number: 490472
  • Primary UDI-DI: 04046964958878
  • Quantity recalled: 10,536 units
  • Distribution: Worldwide
  • Recall Date: October 29, 2025

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Safety Assessment

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

Product Classification

Product TypeAnesthesia IV Set
Sold At
Multiple Retailers

Product Details

Model Numbers
Catalog Number: 490472
Primary UDI-DI: 04046964958878
Unit of Dose UDI-DI: 04046964958861.
Report Date
December 3, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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