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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices

B Braun Medical Inc: Infusomat Space Infusion Pumps Recalled for False Occlusion Alarms

Agency Publication Date: September 7, 2024
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Summary

B Braun Medical Inc. is expanding a recall for 14 Infusomat Space Infusion System/Large Volume Pumps (Product Code 8713050U). These medical pumps can build up static electricity during use, which may cause internal sensors to malfunction and trigger false alarms for blockages that do not exist. This recall expansion includes specific units sold in Alabama, California, Georgia, Illinois, Michigan, and Texas.

Risk

The buildup of electrostatic charge can cause the pump's sensor to stop working correctly, triggering false downstream and upstream occlusion alarms. This can lead to unexpected interruptions in the delivery of critical medications or fluids, potentially harming patients who require precise and continuous infusion therapy.

What You Should Do

  1. Check your medical equipment to see if you have an Infusomat Space Infusion System/Large Volume Pump (Product Code 8713050U).
  2. Verify if your device is part of this recall by checking the serial number on the pump against this list of affected units: 52226, 107529, 123259, 123815, 123843, 139003, 147678, 147721, 147725, 239018, 239165, 239231, 239279, or 339337.
  3. Immediately contact B Braun Medical Inc. or your healthcare provider if you find you are using one of the affected pumps to receive instructions on how to have the device serviced or replaced.
  4. If you are a healthcare professional, identify alternative infusion methods if an affected pump must be removed from service to ensure patient care is not interrupted.
  5. For additional information or questions, contact the FDA recall hotline at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

📋Other Action

Manufacturer-led corrective action for sensor malfunction.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Infusomat Space Infusion System/ Large Volume Pump, Product Code 8713050U
Model / REF:
8713050U
UPC Codes:
04046963716752
Lot Numbers:
Serial Number 52226
Serial Number 107529
Serial Number 123259
Serial Number 123815
Serial Number 123843
Serial Number 139003
Serial Number 147678
Serial Number 147721
Serial Number 147725
Serial Number 239018
Serial Number 239165
Serial Number 239231
Serial Number 239279
Serial Number 339337

Product Images

“Label, 0.9% Sodium Chloride for Injection USP 1000 mL in E3 containers”

“Label, 0.9% Sodium Chloride for Injection USP 1000 mL in E3 containers”

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95093
Status: Active
Manufacturer: B Braun Medical Inc
Sold By: B Braun Medical Inc; Authorized medical device distributors
Manufactured In: United States
Units Affected: 14
Distributed To: Alabama, California, Georgia, Illinois, Michigan, Texas

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · FDA Press Release · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.