BEUDAMED
    FDA Enforcement Class II Terminated

    Volcano SpinVision Sterile Equip cover II; Sterile; General Hospital: These Sterile Equipment covers are provided to cover equipment that is mean to be used in the sterile surgical field but cannot be sterilized. The sterile drapes are put over this equipment in case any sterile items may come into contact with them.

    Recall: Z-1042-2016 · Reported March 9, 2016

    Enforcement

    Recall Number
    Z-1042-2016
    Event ID
    73254
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Volcano Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 9, 2016
    Initiation Date
    February 5, 2016
    Classification Date
    March 3, 2016
    Termination Date
    March 21, 2017
    Address
    2870 Kilgore Rd, N/A, Rancho Cordova, CA, 95670-6133, United States

    Description

    Volcano SpinVision Sterile Equip cover II; Sterile; General Hospital: These Sterile Equipment covers are provided to cover equipment that is mean to be used in the sterile surgical field but cannot be sterilized. The sterile drapes are put over this equipment in case any sterile items may come into contact with them.

    Reason

    Volcano Corporation has identified that certain lot numbers of Volcano R-100 Sterile Equipment Covers may have the incorrect expiry date on the outer shipping box; individually wrapped inner product bears the correct expiry date.

    Code Info

    REF numbers: 891BG and 891BG-10 (10 pack): all lots

    Distribution

    Distributed US (nationwide) and the countries of Australia, South Africa, Canada, New Zealand, Belgium, Japan, and Paraguay.

    Quantity

    1355 total