JAGTOME RX 39-30-260-025 Material Number: M00573100
FDA Recall #Z-0770-2022 — Class II — December 22, 2021
Product Description
JAGTOME RX 39-30-260-025 Material Number: M00573100
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
1447 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: 27465196 27566099 27603464 27641141 27731956 27855806 27998506 28297081 GTIN: 8714729776536
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated