HIGH

B Braun Medical Recalls IV Administration Sets Over Backflow Risk

B Braun Medical recalled IV Administration Sets on October 29, 2025, due to a backflow risk. The recall affects devices used with Infusomat Space, Outlook, and Vista Basic Pumps. Healthcare providers should stop using the product 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 recall includes IV Administration Set, 110 IN. with Catalog Number 490566. The devices were distributed worldwide, including the U.S., Canada, Germany, Guatemala, and Singapore.

The Hazard

The recalled IV Administration Sets may allow medication to backflow from secondary IV containers into primary containers. This could lead to potential medication errors and adverse health effects.

Reported Incidents

No specific injuries or incidents have been reported at this time. The recall was initiated due to the identified risk.

What to Do

Stop using the recalled IV Administration Sets immediately. Follow the recall instructions provided by the manufacturer and contact B Braun Medical or your healthcare provider for further guidance.

Contact Information

For more information, contact B Braun Medical Inc. Visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0718-2026.

Key Facts

  • Catalog Number: 490566
  • Class II recall
  • Stop using the product 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 Classification

Product TypeIV Administration Set
Sold At
Multiple Retailers

Product Details

Model Numbers
1. Catalog Number: 490566
Primary UDI-DI: 04046955275625
Unit of Dose UDI-DI: 04046955275618
Expiration Date: Earliest Exp of Comp or 36mths.
Report Date
December 3, 2025
Recall Status
ACTIVE

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