HIGH

B Braun Medical Recalls IV Administration Sets Over Medication Backflow Risk

B Braun Medical recalled 29,900 IV Administration Sets on October 29, 2025. The recall follows reports of potential medication backflow and inability to prime. Healthcare providers and patients must stop using the device immediately.

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 products include IV SET 15DR 3 CARESITE, 124 IN.; Catalog Number: 470005. These sets were distributed worldwide, including the US, Canada, Germany, Guatemala, and Singapore.

The Hazard

The IV Administration Sets pose a high hazard risk due to the potential for backflow of medication from secondary IV containers into primary IV containers. This could lead to serious health complications.

Reported Incidents

No specific incidents have been reported as of the recall date. The recall is precautionary to prevent potential health risks.

What to Do

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

Contact Information

For more information, contact B Braun Medical Inc. at their customer service number or visit their website.

Key Facts

  • Recalled product: IV Administration Set
  • Catalog Number: 470005
  • Total units recalled: 29,900
  • Recall date: October 29, 2025
  • Distribution: Worldwide

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Safety Assessment

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

Product Classification

Product Details

Model Numbers
1. Catalog Number: 470005
Primary UDI-DI: 04046964297199
Unit of Dose UDI-DI: 04046964297182.
Report Date
December 3, 2025
Recall Status
ACTIVE

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