HIGH

B. Braun Medical IV Administration Set Recall 2025 Affects 5,900 Units Over Backflow Risk

B. Braun Medical Inc recalled 5,900 IV administration sets worldwide, including the United States, after reports of backflow from piggyback to primary IV containers and potential priming failure. The devices are used with Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Hospitals and clinics should stop using the sets and follow manufacturer recall instructions.

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

IV administration sets connect IV solutions to patients and are used with gravity or pump-based delivery systems. They are critical for precise dosing and safe medication administration.

Why This Is Dangerous

Backflow from secondary to primary IV lines and incomplete priming can alter delivered doses and risk patient safety.

Industry Context

This recall is not described as part of a broader industry pattern in the provided notice.

Real-World Impact

Hospitals and clinics may need to replace affected sets promptly; potential delays in therapy if devices are in use.

Practical Guidance

How to identify if yours is affected

  1. Identify catalog numbers 490088 and 490107 on the product label.
  2. Verify UDI-DI: 04046964301889 (primary) and 04046964301872 (dose) for 490088; 04046964302145 (primary) and 04046964302138 (dose) for 490107.
  3. Check expiration dates if visible; earliest expiry allowed per label.

Where to find product info

Refer to the FDA recall page linked in the article and contact B. Braun Medical Inc for instructions.

What timeline to expect

Remediation will be guided by manufacturer communications and hospital supply chains; replacement or repair timelines will be provided by the company.

If the manufacturer is unresponsive

  • Escalate via hospital risk management or procurement contact.
  • Request assistance from B. Braun Medical Inc through official recall channels.

How to prevent similar issues

  • Verify device catalog numbers and UDIs before deployment.
  • Work with suppliers to confirm recall status before purchase.
  • In future, confirm that devices are within recall status before installation.

Documentation advice

Keep the recall notice, product labels, UDIs, and correspondence with the manufacturer for records.

Product Details

Catalog numbers: 490088 and 490107. UDI-DI: 04046964301889 (490088) and 04046964302145 (490107). Unit of Dose UDI-DI: 04046964301872 (490088) and 04046964302138 (490107). Expiration: earliest expiry of component or up to 60 months. Distribution: Worldwide, including US, Canada, Germany, Guatemala, Singapore.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 5,900 units recalled
  • Two catalog numbers: 490088 and 490107
  • UDI-DI: 04046964301889 and 04046964302145
  • Two unit-UDI-DI for dose: 04046964301872 and 04046964302138
  • Worldwide distribution including US, Canada, Germany, Guatemala, Singapore
  • Hazard: backflow risk and occlusion potential

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 Details

Model Numbers
490088
490107
Report Date
December 3, 2025
Recall Status
ACTIVE

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