HIGH

B Braun Medical Recalls IV Administration Sets Due to High Hazard

B Braun Medical recalled 5,900 IV Administration Sets on October 29, 2025. The sets pose a risk of medication backflow and occlusion. Healthcare providers must stop using the devices immediately and follow 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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Product Details

The recalled IV Administration Sets were sold under catalog numbers 490088 and 490107. These sets were distributed worldwide, including the US, Canada, Germany, Guatemala, and Singapore.

The Hazard

The IV Administration Sets may allow backflow of medication from secondary IV containers into primary IV containers. This poses a serious risk of medication errors and patient harm.

Reported Incidents

There are no specific injury reports mentioned in the recall notice. The potential for backflow could lead to severe adverse effects in 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 manufacturer's recall notice.

Contact Information

For more information, visit the B Braun Medical website or call their customer service line. Additional details are available at the FDA enforcement report.

Key Facts

  • 5,900 units recalled
  • Risk of medication backflow
  • Immediate stop-use required
  • Contact manufacturer for instructions

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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: 490088
Primary UDI-DI: 04046964301889
Unit of Dose UDI-DI: 04046964301872
Expiration Date: Earliest Exp of Comp or 60mths. 2. Catalog Number: 490107
Primary UDI-DI: 04046964302145
+2 more
Report Date
December 3, 2025
Recall Status
ACTIVE

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