Medtronic Tourniquet Sets recalled for potential unsealed sterile packing
Medtronic is recalling 1760 tourniquet kits due to potential for unsealed sterile packing. These surgical devices may have compromised sterilization barriers.
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: This is an FDA Class II recall of a surgical medical device with potential for unsealed sterile barrier. No illnesses or injuries have been reported. Per the rubric, when the hazard is theoretical with no reported harm, the maximum score is 3.
Plain-English summary
Medtronic Perfusion Systems is recalling 1760 DLP Tourniquet Kits due to potential for unsealed sterile packing. The recalled products include the DLP 5.5 inch Tourniquet Kit (Model 79004, Lot Number 2023081324) and the DLP 7 inch Tourniquet Kit (Model 79009, Lot Numbers 2023041000, 2023041384, 202305C235).
Unsealed sterile packing on these surgical devices could compromise the sterilization barrier of the tourniquets. These devices are used in medical procedures, and compromised sterility could affect their safety and effectiveness. The devices were distributed worldwide.
Healthcare facilities and customers who have received any of the affected lot numbers should contact Medtronic for guidance. The company will provide information on replacement, return, or proper handling of these devices.
The recalled product
- Product
- Medtronic Tourniquet Sets: a) DLP¿ 5.5 in (14.0 cm) Tourniquet Kit, Model Number 79004, b) DLP¿ 7 in (17.8 cm) Tourniquet Kit, Model Number 79009
- Manufacturer
- Medtronic Perfusion Systems
- Affected units
- 1,760
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 (8)
- a) Model Number 79004
- GTIN 20613994576389
- Lot Numbers: 2023081324
- b) Model Number 79009
- GTIN 20613994576457
- Lot Numbers: 2023041000
- 2023041384
- 202305C235
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 13 recalled by Medtronic Perfusion Systems under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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