medical Class II Updated 2022-08-10

Boston Scientific Corporation recalls EkoSonic Kit 106cm, 12cm TZ The EkoSonic Endovascular Dev

Recalled 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.

Hazard / Issue

Product may be mislabeled.

Issued by

FDA

Affected States: CA, CT, GA, IA, IL, IN, NY, OH, TX, WY
Lot/Code Info: UPN: 500-55112 GTIN: 858593006134 Lot Numbers: 8035075225, 8035075226, 8035075227, 8035075228, 8035075229, 8035075230 8035075231, 8035075232, 8035075233, 8035075234
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