FDA-Device2023-11-15Class II
THERASPHERE ADMIN SET, Article No. 7M2650. Canada only. Sterile, single use administration set used to deliver Yttrium-90 glass microspheres for internal radiation therapy.
B. Braun Medical, Inc.
Hazard
Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to hazardous medication. There is also the potential for life-threatening situations to occur requiring additional medical intervention.
Sold states
Worldwide distribution - US Nationwide and the countries of Canada and Singapore.
Affected count
760 units
Manufactured in
901 Marcon Blvd, Allentown, PA, United States
Products
THERASPHERE ADMIN SET, Article No. 7M2650. Canada only. Sterile, single use administration set used to deliver Yttrium-90 glass microspheres for internal radiation therapy.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0133-2024Don't want to check this manually?
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