CLASS II ONGOING Device recall · Reported 31 Jul 2024 · FDA Enforcement Report
TourniKwik Tourniquet Set (CFN 79012) recalled
Medtronic Perfusion Systems is recalling TourniKwik Tourniquet Set (CFN 79012), distributed nationwide in the US. The recall was initiated on 16 May 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2423-2024
- FDA event ID
- 94856
- Recalling firm
- Medtronic Perfusion Systems, Brooklyn Park, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 16 May 2024
- FDA classified
- 23 Jul 2024
- Reported
- 31 Jul 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 16 May 2024 | Recall initiated by company | |
| 23 Jul 2024 | Classified by FDA | +68 days |
| 31 Jul 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Incorrect component placed in four manufactured lots of the TourniKwik" Tourniquet Set.
Product as listed by the FDA
TourniKwik Tourniquet Set (CFN 79012)
Where it was distributed
Worldwide - US Nationwide distribution in the states of MN, MA, UT, CA, and FL. The countries of Japan and Slovenia.
Questions about this recall
Why was it recalled?
Incorrect component placed in four manufactured lots of the TourniKwik" Tourniquet Set.
Which lots are affected?
Model Number: 79012; Serial Number: 2023020354/UDI: 20613994576358, Serial Number: 2023020355/UDI: 00673978186269, Serial Number: 202304C012/UDI: 20613994576358, and Serial Number: 202305C244/UDI: 20613994576358
Where was it sold?
Worldwide - US Nationwide distribution in the states of MN, MA, UT, CA, and FL. The countries of Japan and Slovenia.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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