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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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High RiskFDA Device
Medical Devices/Monitoring Devices

B Braun Medical Inc: Perfusor Space Syringe Pumps Recalled for Monoject Syringe Incompatibility

Agency Publication Date: July 25, 2024
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Summary

B Braun Medical Inc. is recalling 32,004 Perfusor Space Syringe Pumps because they are no longer compatible with Cardinal Health Monoject syringes following manufacturing changes. Using these syringes with the affected pumps can cause the device to fail to recognize the syringe, leading to serious performance issues such as delivering too much or too little medication. This recall affects five different models of the Perfusor Space system distributed nationwide and in Canada. B Braun is updating its instructions to reflect that Cardinal Health Monoject syringes should no longer be used with these specific pumps.

Risk

Incompatible syringes can lead to pump malfunctions including overdosing, underdosing, therapy delays, or failures in occlusion alarms. These issues can result in significant patient harm, especially when delivering critical life-sustaining medications.

What You Should Do

  1. Identify if you have any of the affected Perfusor Space models: Perfusor Space Infusion Pump System (8713030U), Wireless Syringe Pump (8713031U), PCA Syringe Pump (8713080U), ACM-KIT (8713040U), or Non-Wireless Syringe Pump (8713032U).
  2. Check your inventory for Cardinal Health Monoject syringes, as these are no longer compatible with the listed B Braun Perfusor Space pumps.
  3. Immediately stop using Cardinal Health Monoject syringes with the affected Perfusor Space pumps and switch to a compatible syringe option as listed in the updated device instructions.
  4. Contact your healthcare provider or B Braun Medical Inc. at 200 Boulder Dr, Breinigsville, Pennsylvania, 18031-1532, for further technical instructions or to address performance issues.
  5. For additional information or to report a problem, contact the FDA 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

Stop using incompatible syringes and update instruction protocols.

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

Affected Products

Product: Perfusor Space Infusion Pump System
Model / REF:
8713030U
Lot Numbers:
UDI-DI 4046963716745 (All Serial Numbers)
Product: Perfusor Space Syringe Pump, Wireless
Model / REF:
8713031U
Lot Numbers:
UDI-DI 4046964797958 (All Serial Numbers)
Product: Perfusor PCA Syringe Pump
Model / REF:
8713080U
Lot Numbers:
UDI-DI 4046963915308 (All Serial Numbers)
Product: PERFUSOR SPACE ACM-KIT
Model / REF:
8713040U
Lot Numbers:
UDI-DI 4046963687182 (All Serial Numbers)
Product: Perfusor Space Syringe Pump, Non-Wireless
Model / REF:
8713032U
Lot Numbers:
UDI-DI 04046964797965 (All Serial Numbers)

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94890
Status: Active
Manufacturer: B Braun Medical Inc
Sold By: B Braun Medical Inc; authorized medical distributors
Manufactured In: United States
Units Affected: 5 products (14949; 9943; 1663; 930; 4519)
Distributed To: Nationwide

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 · 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.