Scican Ltd. recalls STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health care provider to sterilize medic…

Recall date

June 22, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2286-2023

FDA classification

Class II

Brand / firm

Scican Ltd.

Sold / distributed

US Nationwide Distribution and in the country of Canada

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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