Recall Z-2286-2023 ยท FLE Sterilizer, Steam
Scican Ltd.
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
| Date | Aug 3, 2023 (initiated Jun 22, 2023) |
| Status | Open, Classified |
| 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. |
| Root cause | Employee error |
| Action | SciCan Ltd issued Urgent Medical Device Recall Letter to Distributors on June 22, 2023. via email. Letter states reason for recall, health risk and action to take: " Please immediately reach out to any customers (end users of the autoclave) who have received an affected unit and inform them that they must stop using their unit until it has been checked and, if needed, the gaskets have been installed (please see the last page of this notification for a list of serial numbers affected that were delivered to your organization). From the information received from you, requested in the next step |
| Quantity | 3 units |
| Distribution | US Nationwide Distribution and in the country of Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K192910 | STATClave G4 Chamber Autoclave Scican , Ltd., Jun 19, 2020 |