FDA recall Z-1491-2022

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.

Reason for recall

Product may be mislabeled.

Distribution

US distribution only - CA, CT, GA, IA, IL, IN, NY, OH, TX, WY

Key facts

Status

Ongoing

Initiation date

2022-05-25

Report date

2022-08-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Maple Grove, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1491-2022