Z-0985-2025 Class II Ongoing
FDA device recall Z-0985-2025 was initiated by Medtronic Perfusion Systems on Dec 12, 2024 and is designated Class II. Reason for recall: Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae. The recall status is ongoing. Affected quantity: 930 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 29, 2025
- Initiation Date
- Dec 12, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 930 units
Product Description
EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr)
Reason for Recall
Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
Distribution Pattern
Worldwide - US Nationwide distribution.
Code Information
Model 77418 UDI-DI: 20763000135618, Lot Numbers: 2022041038; Model 77422 UDI-DI: 20643169485970, Lot Number: 2023020934