Recall Z-0272-2023— Smiths Medical ASD Inc.
Class II · Ongoing
Class II FDA medical device recall by Smiths Medical ASD Inc., initiated 2022-10-10. It names one FDA 510(k) clearance: K111386. Product: 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: 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.
- Recalling firm
- Smiths Medical ASD Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-10-10
- Firm location
- Minneapolis, MN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.