Device product
EkoSonic Kit 135cm, 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-1491-2022
Product summary
- Event
- Event 90528
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 10 units
- Official record key
device-enforcement:Z-1491-2022
Official wording
Reason: Product may be mislabeled.
Code information: UPN: 500-56112 GTIN: 858593006264 Lot Numbers: 8035075263, 8035075264, 8035075265, 8035075266, 8035075267, 8035075268, 8035075269, 8035075270, 8035075271, 8035075272
Distribution pattern: US distribution only - CA, CT, GA, IA, IL, IN, NY, OH, TX, WY
Derived failure modes
-
Labeling or packaging
mislabeled