HIGH

B. Braun Medical IV Administration Set Recall 2025 for Backflow and Occlusion Risk (490437)

B. Braun Medical recalled 4,536 IV administration sets globally after reports of backflow risk and occlusion. The sets labeled catalog 490437 are used with gravity IV administration and pump systems such as Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Patients and healthcare providers should stop using the devices immediately and follow the 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, PREGNANT, PREGNANT

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 deliver fluids and medications from bags or bottles to patients via IV lines. This recall concerns sets compatible with gravity and pump-driven administration.

Why This Is Dangerous

Backflow from secondary piggyback containers into primary IV lines can lead to improper dosing or contamination risk. Occlusion can prevent proper priming of the line, potentially interrupting fluid delivery.

Industry Context

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

Real-World Impact

The hazard is serious for patient safety. Healthcare facilities may need to quarantine affected inventory and implement interim controls to prevent continued use.

Practical Guidance

How to identify if yours is affected

  1. Review catalog number 490437 on the device label or packaging.
  2. Verify Primary UDI-DI 04046964833427 and Unit of Dose UDI-DI 04046964833410.
  3. Check expiration: earliest expiration date across components (up to 24 months).

Where to find product info

UDI-DI codes and catalog numbers are typically on the IV set package and on the product labeling.

What timeline to expect

Refund or replacement processing can take 4-8 weeks after submission, depending on supplier and location.

If the manufacturer is unresponsive

  • Document all communications with the manufacturer.
  • File complaints with your hospital supply chain and regulatory bodies if necessary.
  • Consider escalation to regulatory authorities if the supplier is unresponsive.

How to prevent similar issues

  • When purchasing IV sets, verify catalog numbers and UDI codes.
  • Prefer products with clear backflow prevention features and positive priming performance.
  • Check for updated recalls before stocking inventory.
  • Maintain a robust traceability process for medical devices in use.

Documentation advice

Keep recall notice, purchase receipts, product photos, and all correspondence. Document dates of contact and responses.

Product Details

Catalog Number: 490437 Description: IV ADMIN SET W/ 15 DROPS/ML, 118 IN. Primary UDI-DI: 04046964833427 Unit of Dose UDI-DI: 04046964833410 Expiration Date: Earliest Exp of Comp or 24mths Sold/distributed: Worldwide distribution — US distribution and international distribution to Canada, Germany, Guatemala, and Singapore Quantity recalled: 4,536 units Recall date: 2025-10-29 Manufacturer: B. Braun Medical (BBraun Medical)

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 4,536 units recalled worldwide
  • Catalog Number 490437
  • Primary UDI-DI 04046964833427
  • Unit of Dose UDI-DI 04046964833410
  • Expiration: Earliest Exp of Comp or 24 months
  • Backflow risk and occlusion hazard

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
7/ 10
Affected Groups
GENERALPREGNANTPREGNANTPREGNANTGENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
Catalog Number: 490437
Primary UDI-DI: 04046964833427
Unit of Dose UDI-DI: 04046964833410
Expiration Date: Earliest Exp of Comp or 24mths
Report Date
December 3, 2025
Recall Status
ACTIVE

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