Recall Z-2423-2024
Medtronic Perfusion Systems · initiated May 16, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
TourniKwik Tourniquet Set (CFN 79012)
Codes / lots: Model Number: 79012; Serial Number: 2023020354/UDI: 20613994576358, Serial Number: 2023020355/UDI: 00673978186269, Serial Number: 202304C012/UDI: 20613994576358, and Serial Number: 202305C244/UDI: 20613994576358
Reason for recall
Incorrect component placed in four manufactured lots of the TourniKwik" Tourniquet Set.
FDA-determined cause: Under Investigation by firm
Action taken
Consignees 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.
Details
- Recall number
- Z-2423-2024
- Initiated
- May 16, 2024
- Posted by FDA
- July 23, 2024
- Product code
- GDJ – Clamp, Surgical, General & Plastic Surgery
- Quantity
- 636 units
- Distribution
- Worldwide - US Nationwide distribution in the states of MN, MA, UT, CA, and FL. The countries of Japan and Slovenia.
- Recalling firm
- Medtronic Perfusion Systems, Brooklyn Park, MN