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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/Monitoring Devices

B. Braun Medical, Inc.: Infusomat Large Volume Pumps Recalled for False Upstream Occlusion Alarms

Agency Publication Date: October 25, 2023
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Summary

B. Braun Medical, Inc. is recalling 10,655 Infusomat Large Volume Pump systems, including both wireless and non-wireless battery pack models. The recall was initiated because the device may sound an upstream occlusion alarm when no actual blockage exists, causing the pump to stop delivering medication. This defect is particularly dangerous when high-risk medications are being infused, as an interruption in treatment can lead to hemodynamic instability, medical emergencies, or death. These pumps were distributed nationwide across the United States and in Canada.

Risk

The device's sensor may incorrectly detect a blockage in the IV line, causing the infusion to stop abruptly. This interruption in medication delivery can cause a patient's vital signs to become unstable, potentially leading to permanent organ damage or life-threatening complications.

What You Should Do

  1. Identify your device by checking the model and serial numbers. Affected Wireless models (8713051U) include serial numbers 868497 through 892669, and specifically: 430056, 430119, 430155, 430243, 551518, 685947, 703196, 705968, 726936, 737729, 753364, 774163, 790843, and 814074.
  2. Check Non-Wireless Battery Pack models (8713052U) for serial numbers 878498 through 881897, and specifically: 133238, 133975, 490442, 546815, 559325, 561645, 562713, 593049, 617405, 617409, 618522, 783680, and 810031.
  3. Verify the UDI-DI on the product label: 04046964660887 for wireless models or 04046964708626 for non-wireless models.
  4. Immediately contact your healthcare provider or B. Braun Medical, Inc. for further instructions regarding the continued use or repair of these infusion pumps.
  5. Health care professionals should monitor patients closely for signs of infusion interruption if these devices remain in use before a remedy is implemented.
  6. For additional questions or to report issues, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer notification and medical intervention guidance

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

Affected Products

Product: Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System
Model / REF:
8713051U
UPC Codes:
04046964660887
Lot Numbers:
Serial Numbers: 868497-892669
430056
430119
430155
430243
551518
685947
703196
705968
726936
737729
753364
774163
790843
814074
Product: Infusomat Large Volume Pump, Non-Wireless BATTERY PACK; Volumetric Infusion Pump System
Model / REF:
8713052U
UPC Codes:
04046964708626
Lot Numbers:
Serial Numbers: 878498-881897
133238
133975
490442
546815
559325
561645
562713
593049
617405
617409
618522
783680
810031

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92978
Status: Active
Manufacturer: B. Braun Medical, Inc.
Sold By: Hospitals; Medical facilities
Manufactured In: United States
Units Affected: 2 products (9771; 884)
Distributed To: Nationwide
Agency Last Updated: August 9, 2024

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 ยท 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.