HIGH

B Braun Medical Issues Recall for IV Administration Sets Due to Backflow Risk

B Braun Medical recalled 11,832 IV administration sets on October 29, 2025. The recall affects models catalog numbers 490315, 490331, and 490376. The device poses a risk of medication backflow and occlusion during use.

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 catalog numbers 490315, 490331, and 490376. These products were distributed worldwide, including to the United States, Canada, Germany, Guatemala, and Singapore.

The Hazard

The recalled IV administration sets may allow backflow of medication from secondary IV containers to primary IV containers. This backflow could lead to medication errors and patient harm.

Reported Incidents

There are no reported injuries or deaths associated with this recall. However, the potential for serious complications exists.

What to Do

Patients and healthcare providers should immediately stop using the recalled IV administration sets. Contact B Braun Medical Inc or your healthcare provider for further instructions.

Contact Information

For more information, visit [B Braun Medical](https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0664-2026). You can also reach B Braun Medical directly for assistance.

Key Facts

  • Recalled on October 29, 2025
  • 11,832 units affected
  • Catalog numbers: 490315, 490331, 490376
  • Risk of medication backflow
  • Stop use immediately

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Safety Assessment

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

Product Classification

Product Details

Model Numbers
1. Catalog Number: 490315
Primary UDI-DI: 04046964527173
Unit of Dose UDI-DI: 04046964525612. 2.Catalog Number: 490331
Primary UDI-DI: 04046964541148
Unit of Dose UDI-DI: 04046964541131. 3. Catalog Number: 490376
+2 more
Report Date
December 3, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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