Device product
EkoSonic Kit 106cm, 12cm TZ The EkoSonic Endovascular Device is packaged as a kit that includes both the USC and IC components. They are placed into the respective trays and sealed in a Tyvek pouch. The sealed pouches are placed inside the kit carton (box) and the product labels.
Z-1492-2022
Product summary
- Event
- Event 90528
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 10 units
- Official record key
device-enforcement:Z-1492-2022
Official wording
Reason: Product may be mislabeled.
Code information: UPN: 500-55112 GTIN: 858593006134 Lot Numbers: 8035075225, 8035075226, 8035075227, 8035075228, 8035075229, 8035075230 8035075231, 8035075232, 8035075233, 8035075234
Distribution pattern: US distribution only - CA, CT, GA, IA, IL, IN, NY, OH, TX, WY
Derived failure modes
-
Labeling or packaging
mislabeled