FDA-Device2019-06-05Class I
SOLOPATH Re-Collapsible Access System, Model Numbers SR-1925, SR-1935, SR-2025, SR-2035, SR-2225, SR-2235, SR-2425, SR-2435
Terumo Medical Corporation
Hazard
There is a potential for dislodgement of the tip from the outer diameter of the sheath resulting in a loss of the smooth transition from the surface of the tip to the outer surface of the expandable sheath.
Sold states
The products were distributed US nationwide. The products were distributed to the following foreign countries: Australia, Belgium, Brazil, Canada, Portugal, Hong Kong, Peru, Singapore.
Affected count
1431
Manufactured in
950 Elkton Blvd, N/A, Elkton, MD, United States
Products
SOLOPATH Re-Collapsible Access System, Model Numbers SR-1925, SR-1935, SR-2025, SR-2035, SR-2225, SR-2235, SR-2425, SR-2435
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1375-2019Don't want to check this manually?
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