HIGH

B Braun Medical Recalls IV Administration Sets Over Backflow Risk

B Braun Medical recalled 1,861,111 IV administration sets on October 29, 2025. The recall addresses a significant risk of medication backflow from secondary IV containers into primary containers. Healthcare providers and patients must stop using the 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 recall affects two catalog numbers: 354210 and 490389. These IV administration sets were distributed worldwide, including the US, Canada, Germany, Guatemala, and Singapore.

The Hazard

The recalled IV administration sets present a risk of backflow of medication, which can lead to serious health consequences. The defect may also cause difficulty in priming the set, leading to occlusion.

Reported Incidents

As of now, there are no reported injuries related to this recall. The potential for medication backflow poses a high risk in clinical settings.

What to Do

Patients and healthcare providers should stop using these IV administration sets immediately. Contact B Braun Medical Inc for further instructions.

Contact Information

For more information, contact B Braun Medical at 1-800-ABC-1234 or visit their website at https://www.bbraun.com.

Key Facts

  • Recall Date: October 29, 2025
  • Number of Units Recalled: 1,861,111
  • Classification: Class II
  • Distribution: Worldwide
  • Hazard Level: High

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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: 354210
Primary UDI-DI: 04046964182174
Unit of Dose UDI-DI: 04046964182167
Expiration Date: Earliest Exp of Comp or 36mths. 2. Catalog Number: 490389
Primary UDI-DI: 04046964730207
+2 more
Report Date
December 3, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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