Medfusion Syringe Pump Model 4000 recallZ-2734-2020 · Smiths Medical ASD Inc. · initiated Jun 26, 2020
Class I Open, Classified All recalls posted in August 2020
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
Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs.
FDA root cause category: Software design
What the company is doing
Consignees are being contacted via direct mailing and email. Consignees are asked to review and complete the Recall Response form indicating understanding of notification. Distributors are asked to forward the notification to parties to whom product has been distributed. Smiths Medical will send out 2 additional notifications by email. Phone calls will be made to non-responders.
Recall details
- Recall number
- Z-2734-2020
- Recall class
- Class I (most serious)
- Status
- Open, Classified
- Initiated by the company
- Jun 26, 2020
- Posted by the FDA
- Aug 6, 2020
- Recalling firm
- Smiths Medical ASD Inc.
- Quantity
- 35616 units
- Product code
- FRN
- FDA submissions
- K040899, K111386
- Distribution
- Worldwide distribution - United Arab Emirates, United States, Afghanistan, Albania, Australia, Belgium, Bermuda, Canada, China, Germany, Denmark, Great Britain, Hong Kong, Indonesia, Ireland, India, Korea, Kuwait, Lebanon, Mexico, Malaysia, New Zealand, Oman, Panama, Philippines, Pakistan, Poland, Saudi Arabia, Trinidad and Tobago
Product description
Medfusion Syringe Pump Model 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1
Code information (models, lots, serial numbers)
Model Numbers: 4000-0105-249, 4000-0105-50, 4000-0105-51, 4000-0105-78, 4000-0106-00, 4000-0106-01, and 4000-0106-231. Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1
Other devices under the same FDA submission
15 devices cleared under K040899, 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 3500-500Icu Medical, Inc. · Pump, infusion2 recalls2 deaths1,884 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
Other products in the same recall event
The FDA groups related products into one recall event (event 85912).
- Z-2735-2020 · Open, ClassifiedMedfusion Syringe Pump Model 3500, Software Version V6.0. Infusion pump.
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.
How recalls are matched to devices · Editorial policy · Report an error on this page