HIGH

B Braun Medical Recalls IV Administration Sets Over Backflow Risk

B Braun Medical recalled 111,312 IV administration sets due to a risk of backflow of medication. The sets are used with Infusomat Space, Outlook, and Vista Basic Pump models. The recall was announced on October 29, 2025, following potential safety 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 recall involves IV Administration Sets with catalog numbers 490193 and 490326. These products were distributed worldwide, including the US, Canada, Germany, Guatemala, and Singapore.

The Hazard

The recall addresses a potential backflow of medication from secondary IV containers into primary IV containers. This poses a significant risk of medication errors and patient harm.

Reported Incidents

There were no specific reported incidents or injuries associated with this recall mentioned in the data.

What to Do

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

Contact Information

For more information, contact B Braun Medical Inc. Visit their website or call customer service for instructions regarding the recall.

Key Facts

  • Recalled due to potential medication backflow
  • 111,312 units involved in the recall
  • Immediate action required by healthcare providers and patients
  • Used with specific B Braun Medical pumps

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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: 490193
Primary UDI-DI: 04046964303661
Unit of Dose UDI-DI: 04046964303654
Expiration Date: Earliest Exp of Comp or 24mths. 2. Catalog Number: 490326
Primary UDI-DI: 04046964541063
+2 more
Report Date
December 3, 2025
Recall Status
ACTIVE

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