Z-1316-2024 Class II Ongoing
FDA device recall Z-1316-2024 was initiated by Medtronic Perfusion Systems on Feb 7, 2024 and is designated Class II. Reason for recall: Medtronic is writing to inform you of incorrect labeling for three manufactured lots of the DLP Vessel Cannulae for the model and lot numbers listed above. The recall status is ongoing. Affected quantity: 4343 units.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 27, 2024
- Initiation Date
- Feb 7, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4343 units
Product Description
Medtronic DLP Vessel Cannula, Model Number REF 30000
Reason for Recall
Medtronic is writing to inform you of incorrect labeling for three manufactured lots of the DLP Vessel Cannulae for the model and lot numbers listed above.
Distribution Pattern
US and Brazil, Canada, Republic of Georgia, Germany, India, Ireland, Italy, Malaysia, South Africa, UK
Code Information
UDI/DI 20613994646211, Lot Numbers: 2023020890, 202305C126, 2023020889
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1316-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026