Medtronic TourniKwik Tourniquet Set Recalled for Incorrect Component
Medtronic is recalling 636 units of TourniKwik Tourniquet Sets due to incorrect components placed in four manufactured lots. Distribution includes the US states of Minnesota, Massachusetts, Utah, California, Florida, Japan, and Slovenia.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is FDA Class II for a medical device component defect with no reported illnesses, injuries, or hospitalizations. This qualifies as a risk-of-harm product where injury has not yet been reported, meeting the rubric criterion for High severity.
Plain-English summary
Medtronic Perfusion Systems is recalling 636 units of TourniKwik Tourniquet Sets (CFN 79012) because incorrect components were placed in four manufactured lots. The affected devices are identified by specific serial numbers and UDI codes.
The recalled units were distributed worldwide to the United States, Japan, and Slovenia. Within the US, distribution included Minnesota, Massachusetts, Utah, California, and Florida.
The U.S. Food and Drug Administration classified this recall as Class II. Consumers and healthcare providers who have received this device should refer to Medtronic or the FDA's official recall notice for appropriate action.
The recalled product
- Product
- TourniKwik Tourniquet Set (CFN 79012)
- Manufacturer
- Medtronic Perfusion Systems
- Category
- Medical Device
- Hazard
- Affected units
- 636
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Model Number: 79012
- Serial Number: 2023020354/UDI: 20613994576358
- Serial Number: 2023020355/UDI: 00673978186269
- Serial Number: 202304C012/UDI: 20613994576358
- and Serial Number: 202305C244/UDI: 20613994576358
Distribution
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