Device product
HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3
Z-2239-2026
Product summary
- Event
- Event 98843
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1910 units
- Official record key
device-enforcement:Z-2239-2026
Official wording
Reason: Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers.
Code information: Lot Number: F12607207D
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Singapore.
Derived failure modes
-
Unknown
Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers.