Z-0984-2025 Class II Ongoing
FDA device recall Z-0984-2025 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: 745 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
- 745 units
Product Description
DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 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 77008 UDI-DI: 20763000091105, Lot Numbers: 2024010723, 202404C049; Model 77014 UDI-DI: 20763000091136, Lot Number: 2023121097