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 621103

Recall number

Z-2285-2023

Recalling firm

Scican Ltd.

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 621103

Status

Open, Classified

Initiated

2023-06-22

Posted

2023-08-03

Terminated

not on file

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 below, our sales representatives will be visiting the location of any affected unit to confirm if the gaskets are missing. " Please immediately complete the MEDICAL DEVICE RECALL RETURN RESPONSE, Acknowledgement and Receipt Form included as the last page of this notice. After all information has been completed, sign and return the form to Israa Howlader, copy Stacey Graf, Rich Strader and Teresa Boyce (their contact information is included on the form). " Please also indicate on the attached Acknowledgement and Receipt form that you have received and understood this correction notice. If you have further questions about the product or the recall, please immediately contact Teresa Boyce teresa.boyce@coltene.com, Stacey Graf at stacey.graf@coltene.com or Rich Strader rich.strader@coltene.com. " Once we receive your completed Acknowledgement and Receipt form, we will arrange for one of our sales representatives to visit your customer (the end user) or warehouse where the unit is located to confirm if the gaskets are missing from their unit(s). If the gaskets are missing, in order to apply the correction as soon as possible, our sales representatives will immediately provide the gaskets needed so your trained service technician can install them onto the unit. Please see the attached instructions for directions on how to install the gaskets. (For units that are still in your inve

Quantity

19 units

Distribution

US Nationwide Distribution and in the country of Canada

Lot, serial or model codes

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

510(k) numbers

["K190062"]

PMA numbers

not on file

Product code

FLE

Firm FEI

1000273801

Firm city

North York

Firm state

not on file

Firm country

Canada

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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