Scican STATCLAVE G4 Chamber Autoclave Recall for Sterilization Risk
Scican has recalled 3 STATCLAVE G4 tabletop autoclaves due to risk of incomplete sterilization if used with incompatible loads. Healthcare facilities should verify only compatible materials are sterilized.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm medical device where incomplete sterilization could lead to patient harm through potential cross-contamination. No illnesses or injuries have been reported. The FDA Class II classification and absence of reported incidents support a High severity rating.
Plain-English summary
Scican Ltd. has recalled 3 units of the STATCLAVE G4 Chamber Autoclave, a tabletop steam sterilizer (model G4 622303) intended for use in healthcare settings to sterilize medical and dental instruments using pressurized steam.
The device is not designed to sterilize liquid loads, biomedical waste, or materials that are incompatible with steam sterilization. If the device is used with such incompatible loads, incomplete sterilization may occur, potentially resulting in inadequately sterilized medical instruments being returned to clinical use.
Three affected units with serial numbers 710523E00005, 710523E00006, and 710523E00007 have been distributed nationwide in the United States and in Canada. Healthcare facilities using this device should review device instructions to confirm that only compatible materials are being sterilized.
The recalled product
- Product
- 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
- Manufacturer
- Scican Ltd.
- Hazard
- incomplete-sterilization
Distribution
Distributed nationwide across the United States.
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