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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

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1492-2022
Event ID90528
Event DescriptionEkoSonic 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 TypeDevices
DistributionUS distribution only - CA, CT, GA, IA, IL, IN, NY, OH, TX, WY
Quantity10 units
Recall ReasonProduct may be mislabeled.
Device Classification20220810
Device Code InfoUPN: 500-55112 GTIN: 858593006134 Lot Numbers: 8035075225, 8035075226, 8035075227, 8035075228, 8035075229, 8035075230 8035075231, 8035075232, 8035075233, 8035075234
Center Classification Date20220801
Recall Initiation Date20220525
Recalling FirmBoston Scientific Corporation
Initial Notification Telephone
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