Device product
COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 Units
Z-1578-2023
Product summary
- Event
- Event 92042
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1186 units
- Official record key
device-enforcement:Z-1578-2023
Official wording
Reason: Custom sheath Introducer contains incorrect needle size
Code information: Lot # H2122096S1; UDI-DI: (00)884450525197
Distribution pattern: US Distribution to state of: Minnesota
Derived failure modes
-
Unknown
Custom sheath Introducer contains incorrect needle size