JAGTOME RX 44-20-450-035 Material Number: M00573050
FDA Recall #Z-0774-2022 — Class II — December 22, 2021
Product Description
JAGTOME RX 44-20-450-035 Material Number: M00573050
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
3578 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: 27535120 27643043 27730949 27836207 27571950 27591704 27625065 27773387 GTIN: 8714729776666
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated