STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health care provider to sterilize medica
Summary
The FDA issued a Class II for STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a by Scican Ltd.. Reason: The STATCLAVE G4 is a dynamic air removal (prevacuum) tabletop steam sterilizer intended for use by a health care provider to sterilize medical produc.
Details
Source
Device Recall
External ID
Z-2286-2023
Action Date
2023-08-09
Status
Ongoing
Category
device
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
Lot/Code Info: UDI-DI: (01)07540196001793 Serial Numbers: 710523E00005 710523E00006 710523E00007
Quantity Affected: 3 units
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
US Nationwide Distribution and in the country of Canada
Type: Voluntary: Firm initiated
Recall Initiated: 2023-06-22
Company
North York, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 202 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Scican Ltd. has 3 FDA actions in our database, including 2 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Scican Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Scican Ltd. have FDA actions?
Scican Ltd. has 3 FDA actions in our database, including 2 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2286-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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