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.
FDA Recall Z-0272-2023 · Posted 2022-11-21
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Recalling FirmSmiths Medical ASD Inc.
Recall StatusOpen, Classified
Product CodeFRN
Date Initiated2022-10-10
Product Quantity422 devices
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
Firm Action
Smiths Medical notified consignees initially via telephone on 10/10/2022 and followed up with a letter via email on 10/11/2022. The letter was titled "URGENT MEDICAL DEVICE CORRECTION" and instructed consignees to locate all affected pumps and ensure all users or potential users of these devices are immediately made aware of this notification and proposed mitigations, complete and return the attached Response Form to [email protected], and if Smiths Medical does not contact you to schedule the implementation of the software updates, please contact Smiths Medical Technical Assistance.
For further inquiries, please contact Smiths Medical using the following information:
email: [email protected].
Root Cause
Under Investigation by firm
Distribution Pattern
US distribution to states of: Indiana, Texas and Virginia
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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