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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 Medfusionsee related information
Date Initiated by FirmJune 26, 2020
Date PostedAugust 06, 2020
Recall Status1 Open3, Classified
Recall NumberZ-2734-2020
Recall Event ID 85912
510(K)NumberK040899 K111386 
Product Classification Pump, infusion - Product Code FRN
ProductMedfusion Syringe Pump Model 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1
Code Information 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 
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		Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs.
FDA Determined
Cause 2		Software design
ActionConsignees 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 Commerce35616 units
DistributionWorldwide 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 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 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) Database510(K)s with Product Code = FRN
510(K)s with Product Code = FRN
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