FDA Medical Device Recalls (openFDA)
Medtronic Perfusion Systems: TourniKwik Tourniquet Set (CFN 79012)
- Recall number
- Z-2423-2024
- Recalling firm
- Medtronic Perfusion Systems
- Product
- TourniKwik Tourniquet Set (CFN 79012)
- Status
- Open, Classified
- Initiated
- 2024-05-16
- Posted
- 2024-07-23
- Terminated
- not on file
- Reason
- Incorrect component placed in four manufactured lots of the TourniKwik" Tourniquet Set.
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 636 units
- Distribution
- Worldwide - US Nationwide distribution in the states of MN, MA, UT, CA, and FL. The countries of Japan and Slovenia.
- Lot, serial or model codes
- Model Number: 79012; Serial Number: 2023020354/UDI: 20613994576358, Serial Number: 2023020355/UDI: 00673978186269, Serial Number: 202304C012/UDI: 20613994576358, and Serial Number: 202305C244/UDI: 20613994576358
- 510(k) numbers
- ["K855144"]
- PMA numbers
- not on file
- Product code
- GDJ
- Firm FEI
- 1000116158
- Firm city
- Brooklyn Park
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28