HIGH

B. Braun Medical Infusomat IV Sets Recalled for Backflow and Occlusion Risk (49,330,370 Units)

B. Braun Medical recalled 49,330,370 Infusomat IV sets worldwide after a potential backflow from secondary to primary IV containers and an inability to prime. The recall covers gravity IV sets and pump sets used with Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Stop using any affected sets immediately and contact B. Braun Medical for instructions on refunds or replacement

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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About This Product

Infusion sets enable IV medications to be delivered from a bag or bottle into a patient’s vein. They are used with both gravity and pump-assisted IV systems.

Why This Is Dangerous

Backflow from a secondary IV container into the primary line can lead to incorrect medication dosing. An occlusion can prevent proper priming of the line, risking under- or over-infusion.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Healthcare providers and patients could face delays or interruptions in IV therapy if an affected set is in use. The recall could drive replacement costs and require reeducation on IV administration.

Practical Guidance

How to identify if yours is affected

  1. Review packaging for catalog numbers 362032 through 490101.
  2. Cross-check the product label with the recall catalog numbers.
  3. Verify that the infusion set is intended for Infusomat Space, Outlook, or Vista Basic pumps.

Where to find product info

Recall details available on FDA enforcement page and the manufacturer’s notice.

What timeline to expect

Refunds or replacements typically take 4-8 weeks.

If the manufacturer is unresponsive

  • Document all communications with the supplier.
  • Escalate to FDA consumer safety complaint if encounters are unresolved.
  • Consider legal advice for significant harm or ongoing noncompliance.

How to prevent similar issues

  • Always verify recall status before replacing IV sets.
  • Ask for recall-safe replacements from the supplier.
  • Ensure staff are trained on recognizing catalog numbers and UDI identifiers for IV sets.

Documentation advice

Keep the recall notice, purchase receipts, and all correspondence. Photograph affected packaging and catalog numbers for records.

Product Details

Catalog Numbers: 362032, 362033, 362034, 362043, 362050, 362420, 362431, 362432, 363010, 363019, 363030, 363230, 363419, 363420, 363421, 363422, 363423, 363424, 363430, 363433, 480254, 480255, 480256, 480258, 480263, 490100, 490101. Distribution: Worldwide distribution including US and international markets such as Canada, Germany, Guatemala, and Singapore. Classification: Class II recall. Quantity: 49,330,370 units. Reason: Potential backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). Remedy: Stop using the产品.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 49,330,370 units recalled
  • Worldwide distribution with US and international markets
  • 27 catalog numbers (362032–490101)
  • Hazard: backflow and inability to prime (occlusion)
  • No injuries reported to date
  • Recall date: 2025-10-29; Notice date: 2025-12-03

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

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

Product Classification

Product Details

Model Numbers
362032
362033
362034
362043
362050
+22 more
Report Date
December 3, 2025
Recall Status
ACTIVE

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