HIGH

B Braun Medical Recalls IV Administration Set Over Backflow Risk

B Braun Medical recalled 5,952 IV administration sets on October 29, 2025. The recall stems from a risk of medication backflow from secondary IV containers. This poses a serious health risk for patients receiving treatment.

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 product is labeled under catalog number 490612. It is used in gravity IV administration sets and pump administration sets with BBMI's Infusomat Space, Outlook, and Vista Basic Pumps. The sets were distributed worldwide, including the US, Canada, Germany, Guatemala, and Singapore.

The Hazard

The recall addresses a potential for backflow of medication from secondary IV containers into primary containers. This issue could lead to improper medication delivery and patient health risks.

Reported Incidents

As of now, no specific incidents of injury or death have been reported. The hazard level is classified as high due to the potential risk of medication errors.

What to Do

Stop using the IV administration set immediately. Follow the manufacturer’s recall instructions and contact B Braun Medical Inc or your healthcare provider for guidance.

Contact Information

For more information, contact B Braun Medical Inc. Visit their website or call their customer service for further details.

Key Facts

  • Recalled product: IV Administration Set
  • Catalog Number: 490612
  • Quantity: 5,952 units
  • Recall Date: October 29, 2025
  • Hazard: Medication backflow risk

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Safety Assessment

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

Product Details

Model Numbers
1. Catalog Number: 490612
Primary UDI-DI: 04046955664610
Unit of Dose UDI-DI: 04046955664603
Expiration Date: Earliest Exp of Comp or 36mths.
Report Date
December 3, 2025
Recall Status
ACTIVE

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