Reported Aug 9, 2023 · Ongoing
STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health care provider to sterilize…
Scican Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Scican Ltd. · 100-1440 Don Mills Rd · North York, N/A · N/A
Is this the product you have?
- STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam
- ModelG4 621103
- Lot codes and dates
- UDI-DI(01)07540196001786
- Serial Numbers
710423E00039710423E00034710423E00038710423E00052710423E00033710423E00005710423E00013710423E00036710423E00006710423E00007710423E00037710423E00059710423E00035710423E00055710423E00042710423E00050710423E00045710423E00043710423E00040
- Amount recalled
- 19 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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