Medical device recalls Moderate risk

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

Recall date
November 23, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0551-2016
FDA classification
Class II
Brand / firm
Terumo Medical Corp
Sold / distributed
California

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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