FDA Enforcement
Class II
Ongoing
Medtronic I.M.A. Cannulae: DLP¿ 1 mm Arteriotomy Cannula, Model Number 31001
Recall: Z-1796-2024
·
Reported May 22, 2024
Enforcement
- Recall Number
- Z-1796-2024
- 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 I.M.A. Cannulae: DLP¿ 1 mm Arteriotomy Cannula, Model Number 31001
Reason
Potential for unsealed sterile packing.
Code Info
GTIN 00613994575319, Lot Numbers: 2023041320, 2023041323; GTIN 00673978180465, Lot Numbers: 2023041316, 2023041323; GTIN 20613994575313, Lot Numbers: 2023041316, 2023041318, 2023041320, 2023041323, 202305C146, 202305C154
Distribution
Worldwide distribution.
Quantity
7935 units