BEUDAMED
    FDA Recall Terminated

    Vygon DUALSTOP Red Cap used for intravascular lines Product Code: 9888.00 - Product Usage: Cap used for intravascular lines.

    Recall: Z-1114-2019 · Initiated December 6, 2018

    Recall

    Recall Number
    Z-1114-2019
    Event Number
    81866
    Firm
    Vygon U.S.A.
    FEI Number
    2245270
    Product Code
    FPA
    Status
    Terminated
    Root Cause
    Equipment maintenance
    Initiated
    December 6, 2018
    Terminated
    May 12, 2020
    Address
    2750 Morris Rd, Ste A200, Lansdale, PA, 19446-6083

    Description

    Vygon DUALSTOP Red Cap used for intravascular lines Product Code: 9888.00 - Product Usage: Cap used for intravascular lines.

    Reason

    DualStop Caps defect causing leaks in affected product

    Action

    Vygon issued recall letter on 12/6/18 via email or fax stating the defect, health risk and action to be taken. Distributors were provided with instructions on how to handle product that was further distributed by them. Contact your local sales representative or Vygons Customer Service Department at 1-800-473-5414, or by e-mail at [email protected]

    Distribution

    US Nationwide distribution.

    Quantity

    339,800