HIGH

B Braun Medical Recalls IV Administration Sets Due to Backflow Hazard

B Braun Medical recalled 43,900 IV administration sets on October 29, 2025. The recall affects devices used with Infusomat Space, Outlook, and Vista Basic Pumps. Users must stop using these devices immediately due to a potential medication backflow hazard.

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 the following catalog numbers: V1443, V1447, V1448, and V1484. These products were distributed worldwide, including the U.S., Canada, Germany, Guatemala, and Singapore.

The Hazard

There is a potential for backflow of medication from secondary IV containers into primary containers. This condition may also prevent proper priming, leading to potential medication delivery issues.

Reported Incidents

No specific injury or incident counts were reported. However, the nature of the hazard poses a high risk to patients.

What to Do

Patients and healthcare providers should stop using these devices immediately. Contact B Braun Medical Inc or your healthcare provider for further instructions and to follow the recall process.

Contact Information

For more information, visit the FDA's recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0603-2026.

Key Facts

  • 43,900 units recalled
  • Potential for medication backflow
  • Stop using devices immediately
  • Contact B Braun 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: V1443
Primary UDI-DI: 04046964188350
Unit of Use UDI-DI: 04046964188343. 2. Catalog Number: V1447
Primary UDI-DI: 04046964188411
Unit of Use UDI-DI: 04046964188404. 3. Catalog Number: V1448
+4 more
Report Date
December 3, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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