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Recall Observatory FDA recall evidence

Device product

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 622303

Z-2286-2023

June 22, 2023

Class II

Product summary

Firm
Scican Ltd.
Event
Event 92682
Status
Ongoing
Classification
Class II
Quantity
3 units
Official record key
device-enforcement:Z-2286-2023

Official wording

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 information: UDI-DI: (01)07540196001793 Serial Numbers: 710523E00005 710523E00006 710523E00007

Distribution pattern: US Nationwide Distribution and in the country of Canada

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.