PlainRecalls
FDA Devices Moderate Class II Ongoing

Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that have implemented the Smart Pump Programming (SPP) feature in a clinical treatment environment. Used for infusion of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions, and other therapeutic fluids.

Reported: November 30, 2022 Initiated: October 10, 2022 #Z-0272-2023

Product Description

Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that have implemented the Smart Pump Programming (SPP) feature in a clinical treatment environment. Used for infusion of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions, and other therapeutic fluids.

Reason for Recall

Potential for delay in sending Infusion Start Messages to third-party Electronic Health Record systems which may affect infusion auto-programming on the pump and documentation

Details

Recalling Firm
Smiths Medical ASD Inc.
Units Affected
422 devices
Distribution
US distribution to states of: Indiana, Texas and Virginia
Location
Minneapolis, MN

Frequently Asked Questions

What product was recalled? ▼
Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that have implemented the Smart Pump Programming (SPP) feature in a clinical treatment environment. Used for infusion of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions, and other therapeutic fluids.. Recalled by Smiths Medical ASD Inc.. Units affected: 422 devices.
Why was this product recalled? ▼
Potential for delay in sending Infusion Start Messages to third-party Electronic Health Record systems which may affect infusion auto-programming on the pump and documentation
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 30, 2022. Severity: Moderate. Recall number: Z-0272-2023.

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