HIGH

B Braun Medical Recalls IV Administration Sets Over Medication Backflow Risk

B Braun Medical recalled 18,072 IV administration sets on October 29, 2025. The recall affects the Outlook set utilized with Infusomat Space and Outlook Pumps. The sets pose a high risk of medication backflow and priming issues.

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 is the Outlook IV set with catalog number 354213. The sets were distributed worldwide, including in the US, Canada, Germany, Guatemala, and Singapore. They have an expiration date of up to 36 months.

The Hazard

The IV sets have a potential for medication backflow from secondary containers into primary containers. This issue can lead to serious health risks due to medication mix-ups.

Reported Incidents

No specific incidents have been reported, but the risk associated with medication backflow is significant. The classification of this recall is Class II, indicating a moderate risk.

What to Do

Stop using the recalled IV administration sets immediately. Follow the manufacturer's recall instructions and contact B Braun Medical Inc or your healthcare provider for further instructions.

Contact Information

For more information, contact B Braun Medical Inc. Visit their website or call the customer service line for assistance.

Key Facts

  • Recall date: October 29, 2025
  • Quantity recalled: 18,072 units
  • Distribution: Worldwide
  • Risk classification: Class II
  • Immediate action required

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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: 354213
Primary UDI-DI: 04046964182211
Unit of Dose UDI-DI: 04046964182204
Expiration Date: Earliest Exp of Comp or 36mths.
Report Date
December 3, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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