Device product
DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)
Z-0984-2025
Product summary
- Event
- Event 96015
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 745 units
- Official record key
device-enforcement:Z-0984-2025
Official wording
Reason: Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
Code information: Model 77008 UDI-DI: 20763000091105, Lot Numbers: 2024010723, 202404C049; Model 77014 UDI-DI: 20763000091136, Lot Number: 2023121097
Distribution pattern: Worldwide - US Nationwide distribution.
Derived failure modes
-
Labeling or packaging
Incorrect labeling