THERASPHERE ADMIN SET, Article No. 7M2650. Canada only. Sterile, single use administration set used to deliver Yttrium-90 glass microspheres for internal radiation therapy.
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.
Worldwide distribution - US Nationwide and the countries of Canada and Singapore.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0133-2024