FDA Enforcement
Class II
Ongoing
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
Recall: Z-1798-2024
·
Reported May 22, 2024
Enforcement
- Recall Number
- Z-1798-2024
- Event ID
- 94274
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Medtronic Perfusion Systems
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 22, 2024
- Initiation Date
- March 19, 2024
- Classification Date
- May 10, 2024
- Address
- 7611 Northland Dr N, N/A, Brooklyn Park, MN, 55428-1088, United States
Description
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
Reason
Potential for unsealed sterile packing.
Code Info
a) Model Number 79004, GTIN 20613994576389, Lot Numbers: 2023081324; b) Model Number 79009, GTIN 20613994576457, Lot Numbers: 2023041000, 2023041384, 202305C235
Distribution
Worldwide distribution.
Quantity
1760 units