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U.S. Department of Health and Human Services

Class 2 Device Recall SciCan

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  Class 2 Device Recall SciCan see related information
Date Initiated by Firm June 22, 2023
Date Posted August 03, 2023
Recall Status1 Open3, Classified
Recall Number Z-2285-2023
Recall Event ID 92682
510(K)Number K190062  
Product Classification Sterilizer, steam - Product Code FLE
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
Code Information 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
Recalling Firm/
Scican Ltd.
100-1440 Don Mills Rd
North York Canada
For Additional Information Contact Rich Strader
Manufacturer 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.
FDA Determined
Cause 2
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 in Commerce 19 units
Distribution US Nationwide Distribution and in the country of Canada
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FLE and Original Applicant = SciCan Ltd.