HIGH

B Braun Medical Recalls IV Administration Sets Over Medication Backflow Risk

B Braun Medical recalled 12,700 IV administration sets on October 29, 2025, due to a risk of medication backflow. The affected models include Catalog Number 352062, distributed worldwide including the US, Canada, and Germany. Healthcare providers must 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 includes IV administration sets labeled as PB602VSL NON-VENT SET 103-IN-DR, with Catalog Number 352062. The product was distributed internationally, including to Canada, Germany, Guatemala, and Singapore. These sets were sold through various healthcare channels.

The Hazard

The recall stems from a potential backflow of medication from secondary IV containers into primary containers. This issue could lead to patient safety risks and treatment errors. The devices may also have occlusion issues, preventing proper priming.

Reported Incidents

There have been no reported injuries or deaths associated with the recalled IV administration sets. However, the potential for medication backflow poses a significant risk to patient safety.

What to Do

Stop using the recalled IV administration sets immediately. Follow the recall instructions provided by B Braun Medical. Contact your healthcare provider or B Braun Medical for further instructions.

Contact Information

For more information, contact B Braun Medical Inc. at [insert contact number]. Visit their website for additional details on the recall.

Key Facts

  • 12,700 units recalled
  • Potential medication backflow risk
  • Affected model: Catalog Number 352062
  • Distributed worldwide
  • No reported injuries or deaths

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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: 352062
Primary UDI-DI: 04046964181160
Unit of Use UDI-DI: 04046964181153.
Report Date
December 3, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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