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Recall Observatory FDA recall evidence

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).