HIGH

B Braun Medical Recalls IV Administration Sets Over Medication Backflow Risk

B Braun Medical recalled 190,625 IV administration sets on October 29, 2025. The recall addresses a potential backflow of medication from secondary IV containers. Healthcare providers must stop using the device immediately to prevent serious complications.

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 the following catalog numbers: 490528, 490550, 490605, 490616, and 490654. These products were distributed worldwide, including the US, Canada, Germany, Guatemala, and Singapore. They were sold through multiple retailers.

The Hazard

The recall concerns the potential for backflow of medication from secondary IV containers into primary IV containers and the inability to prime due to occlusion. This situation poses a high risk to patient safety, as it can lead to incorrect medication delivery.

Reported Incidents

There are no reported injuries or incidents related to this recall at this time. However, the potential for serious complications exists if the device is used.

What to Do

Stop using the recalled IV administration sets immediately. Follow the recall instructions provided by B Braun Medical Inc. Healthcare providers should contact B Braun Medical or their healthcare provider for further instructions.

Contact Information

For more information, contact B Braun Medical Inc at the number found on their website. You can also visit the recall notice on the FDA's website at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0669-2026.

Key Facts

  • Recall date: October 29, 2025
  • Quantity recalled: 190,625 units
  • Affected catalog numbers: 490528, 490550, 490605, 490616, 490654
  • Distribution: Worldwide including US, Canada, Germany, Guatemala, Singapore
  • No reported injuries at this time

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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: 490528
Primary UDI-DI: 04046955203284
Unit of Dose UDI-DI: 04046955203277
Expiration Date: Earliest Exp of Comp or 36mths. 2. Catalog Number: 490550
Primary UDI-DI: 04046955270347
+11 more
Report Date
December 3, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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