Device product
DeRoyal ENDOVASCULAR TRACEPACK, REF 89-9350.03
Z-0649-2023
Product summary
- Event
- Event 91134
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 495 kits
- Official record key
device-enforcement:Z-0649-2023
Official wording
Reason: XXX
Code information: Lot Numbers: Lot 56225516 exp 6/1/2024; Lot 56395460 exp 6/1/2024; Lot 56620751 exp 10/1/2024; Lot 56780958 exp 10/1/2024; Lot 57190141 exp 10/1/2024; Lot 57754751 exp 1/1/2025
Distribution pattern: US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi
Derived failure modes
-
Unknown
XXX