HIGH

B Braun Medical Recalls IV Administration Sets Over Backflow Risk

B Braun Medical recalled 66,792 IV Administration Sets on October 29, 2025, due to a potential backflow risk. The recall affects models used with Infusomat Space, Outlook, and Vista Basic Pumps. 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 IV Administration Sets include: 1. Catalog Number: 490241 (IV ADMIN SET HF STOPCOCK, 107 IN.) 2. Catalog Number: 490298 (IV ADMIN SET W/15 DROPS/ML, 116 IN.) 3. Catalog Number: 490360 (IV ADMIN SET, 15 DROP, 4 CARESITE, 119 IN.). These sets were distributed worldwide, including the US, Canada, Germany, Guatemala, and Singapore.

The Hazard

The recall stems from a potential for backflow of medication from secondary IV containers into primary IV containers. This issue may lead to medication errors and pose serious health risks.

Reported Incidents

As of now, there are no reported injuries or deaths associated with this recall. However, the hazard level is classified as high due to the serious implications of backflow.

What to Do

Stop using the IV Administration Sets immediately. Follow the recall instructions provided by B Braun Medical. Contact your healthcare provider or B Braun Medical Inc for further instructions.

Contact Information

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

Key Facts

  • 66,792 units recalled
  • Potential for medication backflow
  • Stop using immediately
  • Contact B Braun Medical for instructions

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Safety Assessment

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

Product Details

Model Numbers
1. Catalog Number: 490241
Primary UDI-DI: 04046964716447
Unit of Dose UDI-DI: 04046964716430. 2. Catalog Number: 490298
Primary UDI-DI: 04046964716829
Unit of Dose UDI-DI: 04046964716812. 3. Catalog Number: 490360
+2 more
Report Date
December 3, 2025
Recall Status
ACTIVE

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