HIGH

B. Braun Medical IV Administration Set Recall Affects 286,400 Units Across Global Pumps (2025)

B. Braun Medical recalls 286,400 IV administration sets used with Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump worldwide. The devices may backflow from secondary IV containers into primary containers and cannot be primed. Stop using the device immediately and follow recall instructions from the manufacturer.

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, PREGNANT, 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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About This Product

IV administration sets connect IV bags to patients to deliver fluids and medications either by gravity or via infusion pumps. They are used widely in hospitals and clinics.

Why This Is Dangerous

Backflow from a secondary IV container into the primary container can alter the dose delivered. Inability to prime can lead to incomplete delivery of the prescribed medication.

Industry Context

This recall is not described as part of a broader industry pattern.

Real-World Impact

Healthcare facilities may need to replace affected sets. The recall affects 286,400 units worldwide, potentially causing operational delays and procurement adjustments.

Practical Guidance

How to identify if yours is affected

  1. Check Catalog Number 354211 on the device label
  2. Verify Primary UDI-DI 04046964182198
  3. Verify Unit of Dose UDI-DI 04046964182181
  4. Confirm expiration date on packaging

Where to find product info

On device label and packaging; recall notice from FDA and manufacturer

What timeline to expect

Remedy processing commonly 4-6 weeks after submission

If the manufacturer is unresponsive

  • Escalate with hospital recall coordinator
  • File a report with the FDA recall page
  • Consult your procurement department

How to prevent similar issues

  • Verify backflow-prevention features for IV sets
  • Cross-check product labels with UDI data before purchasing
  • Establish recall monitoring with suppliers
  • Maintain up-to-date supplier recall lists

Documentation advice

Preserve recall notice; Photograph catalog numbers and UDI codes; Save all correspondence and replacement receipts

Product Details

Catalog Number: 354211 Primary UDI-DI: 04046964182198 Unit of Dose UDI-DI: 04046964182181 Description: IV ADM 15 DROP W/3 CARESITE N/C DUAL Quantity: 286,400 units Distribution: Worldwide; US distribution and international distribution to Canada, Germany, Guatemala and Singapore Expiration: Earliest Expiration of Component or 24 months Sold at: Unknown Price: Unknown

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 286,400 units recalled
  • Catalog Number 354211
  • Primary UDI-DI 04046964182198
  • Unit of Dose UDI-DI 04046964182181
  • Distribution worldwide (US, Canada, Germany, Guatemala, Singapore)
  • Expiration: Earliest Exp of Comp or 24 months

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
7/ 10
Affected Groups
GENERALPREGNANTGENERALPREGNANT
Injury Types
OTHER

Product Details

Model Numbers
Catalog Number: 354211
Primary UDI-DI: 04046964182198
Unit of Dose UDI-DI: 04046964182181
Report Date
December 3, 2025
Recall Status
ACTIVE

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