medical Class I Updated 2019-06-05

Terumo Medical Corporation recalls SOLOPATH Re-Collapsible Access System, Model Numbers SR-1925

Recalled Product

SOLOPATH Re-Collapsible Access System, Model Numbers SR-1925, SR-1935, SR-2025, SR-2035, SR-2225, SR-2235, SR-2425, SR-2435

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:VG26 VH21 VL20 VL29 VN29 WP05 VG02 VG07 VG13 VK29 VL18 WA25 WD02 WE25 WF09 WK01 WK09 WP05 XA09 VG06 VH27 VK04 XA09 VH27 VK07 VL28 WL14 XA30 VF31 VG16 VH21 WE25 WH23 WK01 VG09 VG14 VL14 VP18 WN07 XA09
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