TourniKwik Tourniquet Set (CFN 79012)
FDA device recall Z-2423-2024 · posted 2024-07-23 · Open, Classified
Recall details
- Recalling firm
- Medtronic Perfusion Systems
- Reason for recall
- Incorrect component placed in four manufactured lots of the TourniKwik" Tourniquet Set.
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- GDJ
- Quantity affected
- 636 units
- Distribution
- Worldwide - US Nationwide distribution in the states of MN, MA, UT, CA, and FL. The countries of Japan and Slovenia.
- Date initiated
- 2024-05-16
- Date posted
- 2024-07-23
- Location
- Brooklyn Park, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TOURIQUET KIT WITH SNARE (K855144) | Dlp, Inc. | 1986-02-05 |