HIGH

B Braun Medical Recalls IV Administration Sets Over Backflow Risk

B Braun Medical recalled Outlook IV administration sets on October 29, 2025, due to a potential backflow hazard. The affected products may allow medication to flow back from secondary containers into primary IV containers. This recall affects units distributed worldwide, including the U.S., Canada, Germany, Guatemala, and Singapore.

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 involves the Outlook IV set (Catalog Number: 354214). These sets are utilized with B Braun's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. The sets are part of a worldwide distribution.

The Hazard

The recalled IV sets pose a high hazard risk due to the potential for medication backflow from secondary IV containers into primary IV containers. This could result in improper dosing or medication errors.

Reported Incidents

No specific injuries or incidents have been reported at this time. However, the risk for medication errors due to backflow is significant.

What to Do

Patients and healthcare providers should stop using the affected IV sets immediately. Follow the recall instructions provided by B Braun Medical or contact your healthcare provider for further guidance.

Contact Information

For more information, contact B Braun Medical Inc. at [Insert phone number here] or visit their website for additional resources.

Key Facts

  • Recall date: October 29, 2025
  • Classification: Class II
  • Catalog Number: 354214
  • Worldwide distribution including US and Canada
  • Hazard: Backflow of medication risk

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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: 354214
Primary UDI-DI: 04046964182235
Unit of Dose UDI-DI: 04046964182228
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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