Reported Dec 30, 2015 · Terminated

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

Terumo Medical Corp.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Terumo Medical Corp · 2101 Cottontail Lane · Somerset, NJ · 08873-1277

Is this the product you have?

  • Terumo Surflo Winged Infusion Set with Filter and Needle Protection (Surshield)
  • Product CodeSV-S25FL35
Lot codes and dates
  • Product Code
    • SV-S25FL35 Lot Numbers 1508023
    • 1509011 and 1510004
Amount recalled
80,500 units

Where it was sold

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).

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 1, 2017 · Data as of Sep 19, 5:59 PM UTC

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