Medfusion Syringe Pump, Model 4000. The Model 4000 pump is… recallZ-0610-2020 · Smiths Medical ASD Inc. · initiated Oct 28, 2019
Class I Terminated All recalls posted in December 2019
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Smiths Medical ASD Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
There is an anomaly in Medfusion 4000 Syringe Pump Firmware version 1.7.0 that could potentially result in loss of primary audible and visual battery alarm functionality, and interruption of therapy.
FDA root cause category: Software design
What the company is doing
An Urgent Medical Device recall letter dated 10/28/2019 was sent to customers via email beginning 10/28/2019. The letter identified affected product, stated the issue, and provided instructions for customers to return the pumps. A response form was asked to be returned. Questions can be directed to [email protected].
Recall details
- Recall number
- Z-0610-2020
- Recall class
- Class I (most serious)
- Status
- Terminated
- Initiated by the company
- Oct 28, 2019
- Posted by the FDA
- Dec 12, 2019
- Recalling firm
- Smiths Medical ASD Inc.
- Quantity
- 626 devices
- Product code
- FRN
- FDA submissions
- K111386
- Distribution
- CO, MD, NY
Product description
Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.
Code information (models, lots, serial numbers)
Show the full code information (6k characters)
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Other devices under the same FDA submission
14 devices cleared under K111386 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Medfusion 4000-0106-01Icu Medical, Inc. · ACCESSORIES, PUMP, INFUSION2 recalls4,390 reports
- Medfusion 4000-0105-51Icu Medical, Inc. · ACCESSORIES, PUMP, INFUSION2 recalls2,882 reports
- Medfusion 3500-0600-01Icu Medical, Inc. · Pump, infusion2 recalls2,041 reports
- Medfusion 4000-0101-51Icu Medical, Inc. · Pump, infusion2 recalls1 death1,795 reports
- Medfusion 3500-0600-82Icu Medical, Inc. · Pump, infusion2 recalls89 reports
- MEDFUSION 4000-0106-00Icu Medical, Inc. · ACCESSORIES, PUMP, INFUSION2 recalls10 reports
- Medfusion 3500-0600-00Icu Medical, Inc. · ACCESSORIES, PUMP, INFUSION2 recalls9 reports
- MEDFUSION 4000-0106-231Icu Medical, Inc. · Pump, infusion2 recalls5 reports
- Medfusion 3500-0600-51Icu Medical, Inc. · ACCESSORIES, PUMP, INFUSION2 recalls2 reports
- Medfusion 4000-0105-249Icu Medical, Inc. · Pump, infusion2 recalls1 report
- Medfusion 4000-0105-78Icu Medical, Inc. · ACCESSORIES, PUMP, INFUSION2 recalls0 reports
- MEDFUSION 4000-0107-01Icu Medical, Inc. · Pump, infusion1 recall3 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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