Z-1492-2022 Class II Ongoing
FDA device recall Z-1492-2022 was initiated by Boston Scientific Corporation on May 25, 2022 and is designated Class II. Reason for recall: Product may be mislabeled. The recall status is ongoing. Affected quantity: 10 units.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 10, 2022
- Initiation Date
- May 25, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10 units
Product 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.
Reason for Recall
Product may be mislabeled.
Distribution Pattern
US distribution only - CA, CT, GA, IA, IL, IN, NY, OH, TX, WY
Code Information
UPN: 500-55112 GTIN: 858593006134 Lot Numbers: 8035075225, 8035075226, 8035075227, 8035075228, 8035075229, 8035075230 8035075231, 8035075232, 8035075233, 8035075234
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1492-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026