HIGH

B Braun Medical Recalls Anesthesia IV Sets Over Backflow Risk

B Braun Medical recalled 58,752 Anesthesia IV Sets on October 29, 2025. The recall follows reports of potential backflow of medication from secondary IV containers. This poses a high hazard level for patients using the Infusomat Space and other 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 Anesthesia IV Sets are catalog number 490468, and they are part of gravity IV administration sets and pump administration sets. These products were distributed worldwide, including to the US, Canada, Germany, Guatemala, and Singapore.

The Hazard

The devices have a potential for backflow of medication from secondary IV containers into primary IV containers. This situation can result in improper medication delivery and could lead to serious health complications.

Reported Incidents

As of the recall date, no specific injuries or incidents have been reported. However, the high hazard level indicates a significant risk to patient health.

What to Do

Stop using the recalled Anesthesia IV Sets immediately. Contact B Braun Medical Inc or your healthcare provider for further instructions on the recall process.

Contact Information

For more information, visit the FDA's recall report at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0614-2026 or contact B Braun Medical directly.

Key Facts

  • 58,752 units recalled
  • Catalog Number: 490468
  • Risk of medication backflow
  • Worldwide distribution
  • High hazard level

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Safety Assessment

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

Product Classification

Product TypeAnesthesia IV Set
Sold At
Multiple Retailers

Product Details

Model Numbers
Catalog Number: 490468
Primary UDI-DI: 04046964958793
Unit of Dose UDI-DI: 04046964958786.
Report Date
December 3, 2025
Recall Status
ACTIVE

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