HIGH

B Braun Medical Recalls Anesthesia IV Sets Over Medication Backflow Risk

B Braun Medical recalled 32,436 Anesthesia IV Sets on October 29, 2025. The recall affects specific catalog numbers due to a risk of medication backflow. Healthcare providers must stop using these devices immediately and follow the provided recall instructions.

Quick Facts at a Glance

Recall Date
October 29, 2025
Hazard Level
HIGH
Brand
B Braun Medical
Category
Health & Personal Care
Sold At
Unknown
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 Sets include two catalog numbers: 490189 (IV ADMIN SET W/15 DROPS/ML, 108 IN) and 490226 (IV ADMIN SET 137 IN). These sets were distributed worldwide, including the US, Canada, Germany, Guatemala, and Singapore.

The Hazard

The recall addresses a significant risk of backflow of medication from secondary IV containers into primary IV containers. This malfunction can lead to improper medication delivery and potential patient harm.

Reported Incidents

There are no specific incident numbers reported associated with this recall. However, the potential for medication backflow presents a high risk to patient safety.

What to Do

Stop using the recalled Anesthesia IV Sets immediately. Contact B Braun Medical Inc or your healthcare provider for further instructions and follow the recall guidelines provided in the notification letter.

Contact Information

For more information, reach B Braun Medical Inc at 1-800-854-6851 or visit their website at www.bbraun.com.

Key Facts

  • Recall Date: October 29, 2025
  • Quantity Recalled: 32,436 units
  • Catalog Numbers: 490189, 490226
  • Distribution: Worldwide

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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: 490189
Primary UDI-DI: 04046964303586
Unit of Use UDI-DI: 04046964303579. 2. Catalog Number: 490226
Primary UDI-DI: 04046964304262
Unit of Use UDI-DI: 04046964304255.
Report Date
December 3, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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