Smiths Medical ASD Inc.: 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.

Recall number

Z-0610-2020

Recalling firm

Smiths Medical ASD Inc.

Product

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.

Status

Terminated

Initiated

2019-10-28

Posted

2019-12-12

Terminated

2024-06-06

Reason

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.

Root cause

Software design

Action

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 fieldactions@smiths-medical.com.

Quantity

626 devices

Distribution

CO, MD, NY

Lot, serial or model codes

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510(k) numbers

["K111386"]

PMA numbers

not on file

Product code

FRN

Firm FEI

3012307300

Firm city

Minneapolis

Firm state

MN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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