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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 Pump see related information
Date Initiated by Firm October 28, 2019
Date Posted December 12, 2019
Recall Status1 Open3, Classified
Recall Number Z-0610-2020
Recall Event ID 84232
510(K)Number K111386  
Product Classification Pump, infusion - Product Code FRN
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.
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Recalling Firm/
Manufacturer
Smiths Medical ASD Inc.
6000 Nathan Ln N
Minneapolis MN 55442-1690
For Additional Information Contact Dave 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
Under Investigation by firm
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 in Commerce 626 devices
Distribution CO, MD, NY
Total Product Life Cycle TPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = SMITHS MEDICAL MD, INC.
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