HIGH

B Braun Medical Recalls IV Administration Sets Over Medication Backflow Risk

B Braun Medical recalled 162,648 IV administration sets on October 29, 2025. The products pose a high risk of backflow from secondary IV containers into primary containers. Affected sets include catalog number 354212, distributed worldwide.

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 the Outlook IV Set with catalog number 354212. These sets were distributed globally, including the US, Canada, Germany, Guatemala, and Singapore. The devices were sold as part of gravity and pump administration sets.

The Hazard

The recalled IV administration sets may allow medication to backflow from secondary IV containers into primary containers. This condition could lead to dosing errors and potential patient harm.

Reported Incidents

No specific incidents or injuries have been reported as of the recall date. The potential for serious medication errors remains a significant concern.

What to Do

Stop using the devices immediately. Follow the recall instructions provided by B Braun Medical. Contact your healthcare provider for further guidance.

Contact Information

For more information, contact B Braun Medical at 1-800-227-2862. Visit their website for further details.

Key Facts

  • Recall date: October 29, 2025
  • Quantity recalled: 162,648 units
  • Catalog number: 354212
  • Distribution: Worldwide

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Safety Assessment

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

Product Classification

Product Details

Model Numbers
1. Catalog Number: 354212
Primary UDI-DI: 04046964293832
Unit of Dose UDI-DI: 04046964293825
Expiration Date: Earliest Exp of Comp or 36mths.
Report Date
December 3, 2025
Recall Status
ACTIVE

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