Device product

Terumo Surflo Winged Infusion Set with Filter and Needle Protection (Surshield), Product Code: SV-S25FL35.

Z-0551-2016

November 23, 2015

Class II

Product summary

Firm: Terumo Medical Corp
Event: Event 72828
Status: Terminated
Classification: Class II
Quantity: 80,500 units
Official record key: device-enforcement:Z-0551-2016

Official wording

Reason: Potential improper bonding between the tube and luer for certain lots of Surflo Winged Infusion Set with Filter and Needle Protection (Surshield).

Code information: Product Code: SV-S25FL35 Lot Numbers 1508023, 1509011 and 1510004.

Distribution pattern: California

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Potential improper bonding between the tube and luer for certain lots of Surflo Winged Infusion Set with Filter and Needle Protection (Surshield).