HIGH

B Braun Medical Recalls IV Administration Sets Due to Medication Backflow Risk

B Braun Medical recalled 12,200 IV Administration Sets on October 29, 2025. The recall affects sets used with Infusomat Space, Outlook, and Vista pumps. The recall addresses the risk of medication backflow and occlusion issues.

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 IV Administration Sets include catalog number NF1503 and primary UDI-DI 04046964301445. The products distributed worldwide include U.S. distribution and international shipments to Canada, Germany, Guatemala, and Singapore. The sets were sold until the recall date.

The Hazard

The IV Administration Sets pose a high risk due to potential backflow of medication from secondary IV containers into primary IV containers. This issue can lead to medication errors and serious health risks.

Reported Incidents

There have been no specific incidents reported. However, the potential for backflow could result in adverse medication interactions, posing serious health risks to patients.

What to Do

Stop using the recalled IV Administration Sets immediately. Contact B Braun Medical Inc or your healthcare provider for further instructions and follow the recall instructions provided.

Contact Information

To report issues or for more information, contact B Braun Medical Inc at their website or the provided recall contact number. Additional information is available at the FDA's website.

Key Facts

  • Recalled product: IV Administration Set
  • Catalog number: NF1503
  • Total units recalled: 12,200
  • Hazard: Medication backflow risk
  • Stop use immediately.

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Safety Assessment

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

Product Classification

Product TypeIV Administration Set
Sold At
Multiple Retailers

Product Details

Model Numbers
1. Catalog Number: 490062
Primary UDI-DI: 04046964301445
Unit of Dose UDI-DI: 04046964301438
Expiration Date: Earliest Exp of Comp or 60mths.
Report Date
December 3, 2025
Recall Status
ACTIVE

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