Food, drugs, devices › Smiths Medical ASD Inc.
Device recall: Medfusion Syringe Pump 4000 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Admini
FDA enforcement event 78922 is a device recall by Smiths Medical ASD Inc. of Minneapolis, MN, initiated 13 Nov 2017 and classified Class II, with 3 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 16 Sep 2025. Initiation: voluntary: firm initiated. Smiths Medical ASD Inc. has 108 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Smiths Medical ASD Inc., Minneapolis, MN.
Reason for recall
"Certain Medfusion Syringe Pump Models, Series 3100, 3500, and 4000, may not recognize or may misidentify loaded medication syringes. The inability of a pump to recognize a syringe (i.e. the size of the syringe is unknown to the pump) results in an inability to complete pump programming. Misidentification of a syringe is where the pump misinterprets the syringe size."
Distribution
"Worldwide distribution- US nationwide Distribution and to the countries of : Australia, Barbados, Canada, Hong Kong, Indonesia, Jamaica, New Zealand, Philippines, Saudi Arabia, Singapore, South…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1134-2018 | Medfusion Syringe Pump 4000 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2) By the following… | 16,600 pumps total | Class II | Terminated | 28 Mar 2018 |
| Z-1135-2018 | Medfusion Syringe Pump 3500 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2) By the following… | 16,600 pumps total | Class II | Terminated | 28 Mar 2018 |
| Z-1136-2018 | Medfusion Syringe Pump 3010 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2) By the following… | 16,600 pumps total | Class II | Terminated | 28 Mar 2018 |
Context
Other enforcement events for Smiths Medical ASD Inc.
All 108 events for Smiths Medical ASD Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Certain Medfusion Syringe Pump Models, Series 3100, 3500, and 4000, may not recognize or may misidentify loaded medication syringes. The inability of a pump to recognize a syringe (i.e. the size of the syringe is unknown to the pump) results in an inability to complete pump programming. Misidentification of a syringe is where the pump misinterprets the syringe size."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution- US nationwide Distribution and to the countries of : Australia, Barbados, Canada, Hong Kong, Indonesia, Jamaica, New Zealand, Philippines, Saudi Arabia, Singapore, South…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 16 Sep 2025. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.