Device recall: Medfusion Syringe Pump, Model 3500-500, v3, v4, v5, and v6
Class II FDA enforcement event 92956. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failure Alarm. If the force sensor calibration shift is large enough, the pump will display a System Failure Alarm (including Force Sensor BGND Test, Force Sensor Bridge Test, or Force Sensor Test). However, if the calibration shift is not…
Class II, in the words of FDA
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
Smiths Medical ASD Inc. started this device recall on 16 Aug 2023. The firm address in the FDA record is in Minneapolis, MN. FDA put the recall in Class II. FDA event 92956 has 6 product records. The first FDA enforcement report date is 18 Oct 2023. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide distribution - US Nationwide and the country of Canada.
Recalling firm
Smiths Medical ASD Inc., Minneapolis, MN.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
6 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0076-2024 | Medfusion Syringe Pump, Model 3500-500, v3, v4, v5, and v6 | 20815 pumps | Class II | Ongoing | 18 Oct 2023 |
| Z-0077-2024 | Medfusion Syringe Pump, Model 3500VX-500, v3, v4, v5, and v6 | 111 pumps | Class II | Ongoing | 18 Oct 2023 |
| Z-0078-2024 | Medfusion Syringe Pump, Model 3500-0600-XX: a) 0600-00; b) 0600-01; c) 0600-50; d) 0600-51; e) 0600-82; f) 0600-249; software versions: v3, v4, v5, and v6 | 20383 pumps | Class II | Ongoing | 18 Oct 2023 |
| Z-0079-2024 | Medfusion Syringe Pump, Model 4000-XXXX-XX: a) 0100-50, b) 0100-249, c) 0101-50, d) 0101-51, e) 0101-78, f) 0101-249, g) 0105-51, h) 0105-78, i) 0105-249, j) 0106-00, k) 0106-01, l) 0106-231, m) 0107-01, software versions: v3, v4, v5, and v6 | 67507 pumps | Class II | Ongoing | 18 Oct 2023 |
| Z-0080-2024 | Medfusion PLUNGER FLOAT PLATE, Component Number G6000069, used on infusion pump | 674 units | Class II | Ongoing | 18 Oct 2023 |
| Z-0081-2024 | Medfusion ASSEMBLY PLUNGER CASE LEFT 1/EA, Component Number G6001587, used on infusion pump | 118 units | Class II | Ongoing | 18 Oct 2023 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2023
- 917
- Share of these events in Class II
- 88%
- Product records in this event
- 6Median of the firm: 1
- Events of the firm on the register
- 108
Other events of the firm
Official channels
- FDA enforcement report Z-0076-2024The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 92956. https://recallregister.com/fda/ii/92956/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide distribution - US Nationwide and the country of Canada.
- What quantity of product is in FDA event 92956?
- The event has 6 product records. The first record gives this quantity:
20815 pumps
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2023 have the same class?
- 88% of the 917 device events that started in 2023 are in Class II.