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Boston Scientific Corporation recalls DREAMTOME 44-30MM/450CM Material Number: M00584070
Recalled March 23, 2022 · FDA recall Z-0754-2022 · Boston Scientific
Hazard
Sterility of device is compromised due to a sterile barrier breach · FDA Class II
Units
142 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
DREAMTOME 44-30MM/450CM Material Number: M00584070
Manufacturer(s)
Boston Scientific Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →