JAGTOME REVOLUTION RX 39-20-260-025 Material Number: M00584240
FDA Recall #Z-0765-2022 — Class II — December 22, 2021
Product Description
JAGTOME REVOLUTION RX 39-20-260-025 Material Number: M00584240
Reason for Recall
Sterility of device is compromised due to a sterile barrier breach
Recalling Firm
Boston Scientific Corporation — Marlborough, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
7115 units
Distribution
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Botswana, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Mauritius, Morocco, Namibia, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Unit. Arab Emir.
Code Information
Lot Numbers: 27481920 27524107 27525279 27530542 27574053 27598798 27652479 27722062 27722511 27742261 27758891 27795634 27846706 27897451 27969768 28027118 28070708 GTIN: 8714729953234
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated