Recall Z-2423-2024 ยท GDJ Clamp, Surgical, General & Plastic Surgery
Medtronic Perfusion Systems
TourniKwik Tourniquet Set (CFN 79012)
| Date | Jul 23, 2024 (initiated May 16, 2024) |
| Status | Open, Classified |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K855144 | TOURIQUET KIT WITH SNARE Dlp, Inc., Feb 5, 1986 |