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U.S. Department of Health and Human Services

Class 1 Device Recall Medfusion Model 4000 Pump

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 Class 1 Device Recall Medfusion Model 4000 Pumpsee related information
Date Initiated by FirmOctober 28, 2019
Date PostedDecember 12, 2019
Recall Status1 Terminated 3 on June 06, 2024
Recall NumberZ-0610-2020
Recall Event ID 84232
510(K)NumberK111386 
Product Classification Pump, infusion - Product Code FRN
ProductMedfusion 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.
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Recalling Firm/
Manufacturer
Smiths Medical ASD Inc.
6000 Nathan Ln N
Minneapolis MN 55442-1690
For Additional Information ContactDave Halverson
763-383-3072
Manufacturer Reason
for Recall
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 Determined
Cause 2
Software design
ActionAn 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 in Commerce626 devices
DistributionCO, MD, NY
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = FRN
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