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Boston Scientific Corporation recalls EkoSonic Kit 135cm, 12cm TZ The EkoSonic Endovascular Device is packaged as a kit that includes both the USC and IC c
Recalled August 10, 2022 · FDA recall Z-1491-2022 · Boston Scientific
Hazard
Product may be mislabeled. · FDA Class II
Units
10 units
Sold at
US distribution only - CA, CT, GA, IA, IL, IN, NY, OH, TX, WY
Description
Product may be mislabeled.
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.
Manufacturer(s)
Boston Scientific Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →