Z-0986-2025 Class II Ongoing
FDA device recall Z-0986-2025 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: 440 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
- 440 units
Product Description
Select Series Angled Tip Arterial Cannula, Model Number 72422 (22 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 72422 UDI-DI: 20643169485970, Lot Numbers: 2023071075, 202309C075