Z-0985-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- January 29, 2025
- Initiation Date
- December 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