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.
Reported: August 10, 2022 Initiated: May 25, 2022 #Z-1491-2022
Product Description
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.
Reason for Recall
Product may be mislabeled.
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 10 units
- Distribution
- US distribution only - CA, CT, GA, IA, IL, IN, NY, OH, TX, WY
- Location
- Maple Grove, MN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Boston Scientific Corporation. Units affected: 10 units.
Why was this product recalled? ▼
Product may be mislabeled.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 10, 2022. Severity: Moderate. Recall number: Z-1491-2022.
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