BEUDAMED
    FDA Enforcement Class II Ongoing

    STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. Model: G4 621103

    Recall: Z-2285-2023 · Reported August 9, 2023

    Enforcement

    Recall Number
    Z-2285-2023
    Event ID
    92682
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Scican Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 9, 2023
    Initiation Date
    June 22, 2023
    Classification Date
    August 2, 2023
    Address
    100-1440 Don Mills Rd, N/A, North York, N/A, N/A, Canada

    Description

    STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. Model: G4 621103

    Reason

    The STATCLAVE G4 is a dynamic air removal (prevacuum) tabletop steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. It is suitable for the sterilization of dental and medical instruments that are validated to be sterilized by steam. The STATCLAVE G4 has not been designed to sterilize liquid loads, bio medical waste or materials not compatible with steam sterilization. The processing of such loads may result in incomplete sterilization and / or damage to the autoclave.

    Code Info

    UDI-DI: (01)07540196001786 Serial Numbers: 710423E00039 710423E00034 710423E00038 710423E00052 710423E00033 710423E00005 710423E00013 710423E00036 710423E00006 710423E00007 710423E00037 710423E00059 710423E00035 710423E00055 710423E00042 710423E00050 710423E00045 710423E00043 710423E00040

    Distribution

    US Nationwide Distribution and in the country of Canada

    Quantity

    19 units