Z-2286-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- August 9, 2023
- Initiation Date
- June 22, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 units
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 622303
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.
Distribution Pattern
US Nationwide Distribution and in the country of Canada
Code Information
UDI-DI: (01)07540196001793 Serial Numbers: 710523E00005 710523E00006 710523E00007