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Boston Scientific Corporation recalls JAGTOME RX 49-20-260-035 Material Number: M00573000
Recalled March 23, 2022 · FDA recall Z-0777-2022 · Boston Scientific
Hazard
Sterility of device is compromised due to a sterile barrier breach · FDA Class II
Units
101 units
Sold at
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.
Description
Sterility of device is compromised due to a sterile barrier breach
Product
JAGTOME RX 49-20-260-035 Material Number: M00573000
Manufacturer(s)
Boston Scientific Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →