PlainRecalls
FDA Devices Moderate 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

Reported: August 9, 2023 Initiated: June 22, 2023 #Z-2285-2023

Product 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 for Recall

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.

Details

Recalling Firm
Scican Ltd.
Units Affected
19 units
Distribution
US Nationwide Distribution and in the country of Canada
Location
North York, N/A

Frequently Asked Questions

What product 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 621103. Recalled by Scican Ltd.. Units affected: 19 units.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on August 9, 2023. Severity: Moderate. Recall number: Z-2285-2023.