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U.S. Department of Health and Human Services

Class 1 Device Recall Medfusion

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  Class 1 Device Recall Medfusion see related information
Date Initiated by Firm June 26, 2020
Date Posted August 06, 2020
Recall Status1 Open3, Classified
Recall Number Z-2735-2020
Recall Event ID 85912
510(K)Number K040899  K111386  
Product Classification Pump, infusion - Product Code FRN
Product Medfusion Syringe Pump Model 3500, Software Version V6.0. Infusion pump.
Code Information Model Numbers: 3500-0600-00, 3500-0600-01, 3500-0600-249, 3500-0600-50, 3500-0600-51, 3500-0600-82. Software Version V6.0 
Recalling Firm/
Smiths Medical ASD Inc.
6000 Nathan Ln N
Minneapolis MN 55442-1690
For Additional Information Contact Dave Halverson
Manufacturer Reason
for Recall
Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs.
FDA Determined
Cause 2
Software design
Action 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.
Quantity in Commerce 17019 units
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
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 = MEDEX, INC.
510(K)s with Product Code = FRN and Original Applicant = SMITHS MEDICAL MD, INC.