FDA-Device2022-03-23Class II
DREAMTOME 44-30MM/450CM Material Number: M00584070
Boston Scientific Corporation
Hazard
Sterility of device is compromised due to a sterile barrier breach
Sold states
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.
Affected count
142 units
Manufactured in
100 Boston Scientific Way, N/A, Marlborough, MA, United States
Products
DREAMTOME 44-30MM/450CM Material Number: M00584070
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0754-2022Don't want to check this manually?
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