BEUDAMED
    FDA Enforcement Class II Terminated

    Guidezilla II Guide Extension Catheter Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7493933515060, 6F; 2. REF/Catalog No H7493933515070, 7F.

    Recall: Z-0578-2020 · Reported December 4, 2019

    Enforcement

    Recall Number
    Z-0578-2020
    Event ID
    84152
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Boston Scientific Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    December 4, 2019
    Initiation Date
    October 24, 2019
    Classification Date
    November 26, 2019
    Termination Date
    March 20, 2023
    Address
    1 Scimed Pl, Maple Grove, MN, 55311-1565, United States

    Description

    Guidezilla II Guide Extension Catheter Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7493933515060, 6F; 2. REF/Catalog No H7493933515070, 7F.

    Reason

    Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices, during the manufacturing process.

    Code Info

    Lot / GTIN Number / Use By: 1. 23485544 / 8714729939450 / 2021-02-10, 23933296 / 8714729939450 /2021-05-10, 23947883 / 8714729939450 / 2021-05-12, 24137846 / 8714729939450 / 2021-06-17. 2. Lots: 21305995 / 8714729939474 / 2019-09-25, 24201181 / 8714729939474 / 2021-06-30.

    Distribution

    Nationwide including Washington D.C. and Puerto Rico. OUS to include Canada.

    Quantity

    14,145 devices total