HIGH

B. Braun Medical Inc. IV Administration Set Recalled for Backflow and Priming Occlusion (490407)

B Braun Medical Inc. recalled 10,896 IV administration sets globally due to backflow risk and occlusion. The recall covers the IV ADMIN SET W/ CARESITE EXT SET with Catalog Number 490407 used with BBMI pumps. Patients and healthcare providers should stop using the device immediately and follow manufacturer instructions.

Quick Facts at a Glance

Recall Date
October 29, 2025
Hazard Level
HIGH
Brands
BB Braun Medical, B Braun Medical
Category
Health & Personal Care
Sold At
Unknown
At-Risk Groups
GENERAL, PREGNANT, PETS

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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About This Product

IV administration sets enable intravenous therapy by delivering medications and fluids. The specific BBraun set supports gravity and pump-driven administration.

Why This Is Dangerous

Backflow can cause unintended dosing or contamination of the primary IV line. Occlusion can prevent priming, possibly delaying treatment.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

High risk for incorrect dosing and delays in therapy; requires immediate supplier guidance and potential replacement.

Practical Guidance

How to identify if yours is affected

  1. Check catalog number 490407 on the product packaging or accompanying documentation
  2. Verify UDI-DI 04046964773242 and Unit of Dose UDI-DI 04046964773235
  3. Confirm expiration date: earliest expiry or within 36 months of manufacture
  4. Note the date of sale if available

Where to find product info

FDA recall page Z-0687-2026 and BBraun Medical recall communications

What timeline to expect

Remedies and replacements typically take weeks to a few months depending on supply

If the manufacturer is unresponsive

  • Document all contact attempts
  • File with hospital biomedical engineering for guidance
  • Consider notifying the hospital's recall liaison or risk manager

How to prevent similar issues

  • Implement strict labeling for infusion sets
  • Verify catalog numbers and UDIs before use
  • Maintain inventory controls to segregate recalled lots
  • Review infection control and administration protocols to prevent backflow incidents

Documentation advice

Keep copies of recall notices, UDI data, purchase records, and correspondence with BBraun Medical

Product Details

IV Administration Set W/ CARESITE EXT SET, Catalog Number 490407. Global distribution includes US, Canada, Germany, Guatemala, and Singapore. Unit quantity in recall: 10,896.

Reported Incidents

No specific incidents or injuries are described in the provided data.

Key Facts

  • 10,896 units recalled
  • Catalog Number 490407
  • Primary UDI-DI 04046964773242
  • Unit of Dose UDI-DI 04046964773235
  • Expiration: earliest expiry or 36 months from manufacture
  • Recall date: 2025-10-29; Status: ACTIVE

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERALPREGNANTPETSINFANTSCHILDRENELDERLYPREGNANTPREGNANT
Injury Types
LACERATIONBURNELECTRICALPOISONINGSUFFOCATIONOTHER

Product Details

Model Numbers
490407
Report Date
December 3, 2025
Recall Status
ACTIVE

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