FDA-Device2021-08-25Class II
TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE)
Boston Scientific Corporation
Hazard
Potential for leaks and loosening at the patient catheter connection
Sold states
Worldwide distribution - US Nationwide and the countries of Belgium, Canada, Germany, Spain, France, United Kingdom/Great Britain, Hong Kong, Ireland, Israel, India, Italy, Netherlands, Poland, Portugal, Saudi Arabia, Singapore, Switzerland, Turkey, and Argentina.
Affected count
4980 sets
Manufactured in
1 Scimed Pl, N/A, Maple Grove, MN, United States
Products
TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2327-2021Don't want to check this manually?
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