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U.S. Department of Health and Human Services

Class 2 Device Recall TourniKwik Tourniquet Set

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 Class 2 Device Recall TourniKwik Tourniquet Setsee related information
Date Initiated by FirmMay 16, 2024
Date PostedJuly 23, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2423-2024
Recall Event ID 94856
510(K)NumberK855144 
Product Classification Clamp, surgical, general & plastic surgery - Product Code GDJ
ProductTourniKwik Tourniquet Set (CFN 79012)
Code Information Model Number: 79012; Serial Number: 2023020354/UDI: 20613994576358, Serial Number: 2023020355/UDI: 00673978186269, Serial Number: 202304C012/UDI: 20613994576358, and Serial Number: 202305C244/UDI: 20613994576358
FEI Number 1000116158
Recalling Firm/
Manufacturer		 Medtronic Perfusion Systems
7611 Northland Dr N
Brooklyn Park MN 55428-1088
For Additional Information ContactMedtronic Customer Service
800-854-3570
Manufacturer Reason
for Recall		Incorrect component placed in four manufactured lots of the TourniKwik" Tourniquet Set.
FDA Determined
Cause 2		Under Investigation by firm
ActionConsignees were notified of the recall via mail beginning on 05/16/2024. Consignees were instructed to review inventory for listed product, immediately identify and quarantine all unused, listed product in inventory, return unused, listed product in the inventory to Medtronic, complete the customer confirmation form, and share the notification with orders in the organization.
Quantity in Commerce636 units
DistributionWorldwide - US Nationwide distribution in the states of MN, MA, UT, CA, and FL. The countries of Japan and Slovenia.
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 = GDJ
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