Scican Ltd. Recall 92682
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
Scican Ltd. Recall 92682 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2285-2023 |
| Event ID | 92682 |
| Event 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 |
| Product Type | Devices |
| Distribution | US Nationwide Distribution and in the country of Canada |
| Quantity | 19 units |
| Recall 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. |
| Device Classification | 20230809 |
| Device Code Info | UDI-DI: (01)07540196001786 Serial Numbers: 710423E00039 710423E00034 710423E00038 710423E00052 710423E00033 710423E00005 710423E00013 710423E00036 710423E00006 710423E00007 710423E00037 710423E00059 710423E00035 710423E00055 710423E00042 710423E00050 710423E00045 710423E00043 710423E00040 |
| Center Classification Date | 20230802 |
| Recall Initiation Date | 20230622 |
| Recalling Firm | Scican Ltd. |
| Initial Notification | |
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