Device 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
Z-1798-2024
Product summary
- Event
- Event 94274
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1760 units
- Official record key
device-enforcement:Z-1798-2024
Official wording
Reason: Potential for unsealed sterile packing.
Code information: a) Model Number 79004, GTIN 20613994576389, Lot Numbers: 2023081324; b) Model Number 79009, GTIN 20613994576457, Lot Numbers: 2023041000, 2023041384, 202305C235
Distribution pattern: Worldwide distribution.
Derived failure modes
-
Unknown
Potential for unsealed sterile packing.