BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0551-2016 · Reported December 30, 2015

    Enforcement

    Recall Number
    Z-0551-2016
    Event ID
    72828
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Terumo Medical Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 30, 2015
    Initiation Date
    November 23, 2015
    Classification Date
    December 24, 2015
    Termination Date
    August 1, 2017
    Address
    2101 Cottontail Lane, N/A, Somerset, NJ, 08873-1277, United States

    Description

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

    Reason

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

    Code Info

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

    Distribution

    California

    Quantity

    80,500 units