Z-1796-2024 Class II Ongoing
FDA device recall Z-1796-2024 was initiated by Medtronic Perfusion Systems on Mar 19, 2024 and is designated Class II. Reason for recall: Potential for unsealed sterile packing. The recall status is ongoing. Affected quantity: 7935 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 22, 2024
- Initiation Date
- Mar 19, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7935 units
Product Description
Medtronic I.M.A. Cannulae: DLP¿ 1 mm Arteriotomy Cannula, Model Number 31001
Reason for Recall
Potential for unsealed sterile packing.
Distribution Pattern
Worldwide distribution.
Code Information
GTIN 00613994575319, Lot Numbers: 2023041320, 2023041323; GTIN 00673978180465, Lot Numbers: 2023041316, 2023041323; GTIN 20613994575313, Lot Numbers: 2023041316, 2023041318, 2023041320, 2023041323, 202305C146, 202305C154
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1796-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026