HIGH

B Braun Medical Recalls IV Administration Sets Over Backflow Risk

B Braun Medical recalled 4,536 IV administration sets on October 29, 2025. The recall affects devices that may allow backflow of medication from secondary IV containers. This poses a high risk to patients using the Infusomat Space, Outlook, and Vista Basic pumps.

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 IV Administration Set with 15 drops/ml, 118 inches long. The catalog number is 490437. These sets were distributed worldwide, including the U.S., Canada, Germany, Guatemala, and Singapore.

The Hazard

The IV Administration Sets may allow backflow of medication from secondary containers into primary containers. This could result in medication errors and potential harm to patients.

Reported Incidents

No specific incidents have been reported, but the potential for serious medication errors creates a high-risk situation.

What to Do

Stop using the IV Administration Set immediately. Contact B Braun Medical Inc or your healthcare provider for further instructions and to obtain a refund.

Contact Information

For more information, visit B Braun Medical's website or contact their customer service at 1-800-XXX-XXXX.

Key Facts

  • Recalled product: IV Administration Set, Catalog Number: 490437
  • Total units recalled: 4,536
  • Recall date: October 29, 2025
  • Potential for medication backflow and occlusion
  • Contact manufacturer for return 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: 490437
Primary UDI-DI: 04046964833427
Unit of Dose UDI-DI: 04046964833410
Expiration Date: Earliest Exp of Comp or 24mths.
Report Date
December 3, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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