Boston Scientific Corporation Recall 90528
Description: 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.
Boston Scientific Corporation Recall 90528 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1492-2022 |
| Event ID | 90528 |
| Event Description | 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. |
| Product Type | Devices |
| Distribution | US distribution only - CA, CT, GA, IA, IL, IN, NY, OH, TX, WY |
| Quantity | 10 units |
| Recall Reason | Product may be mislabeled. |
| Device Classification | 20220810 |
| Device Code Info | UPN: 500-55112 GTIN: 858593006134 Lot Numbers: 8035075225, 8035075226, 8035075227, 8035075228, 8035075229, 8035075230 8035075231, 8035075232, 8035075233, 8035075234 |
| Center Classification Date | 20220801 |
| Recall Initiation Date | 20220525 |
| Recalling Firm | Boston Scientific Corporation |
| Initial Notification | Telephone |
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