Home / Recalls / Medical Devices
Boston Scientific Corporation recalls DREAMTOME 44-30MM/260CM Material Number: M00584050
Recalled March 23, 2022 · FDA recall Z-0753-2022 · Boston Scientific
Hazard
Sterility of device is compromised due to a sterile barrier breach · FDA Class II
Units
12067 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/260CM Material Number: M00584050
Manufacturer(s)
Boston Scientific Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →