medical Class I Updated 2019-06-05

Terumo Medical Corporation recalls Portico Solo Re-Collapsible Access System , Model Numbers PR

Recalled Product

Portico Solo Re-Collapsible Access System , Model Numbers PRTSOLO-19, PRTSOLO-20

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Codes: VG29 VH28 VK09 VM20 VN08 VP07 WM03 WM31 VG05 VG09 VG21 VK18 VL25 VM11 VN17 VN27 WM03 WM17
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