STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer… recallZ-2286-2023 · Scican Ltd. · initiated Jun 22, 2023

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.

FDA root cause category: Employee error

What the company is doing

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 [email protected], Stacey Graf at [email protected] or Rich Strader [email protected]. " 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

Recall details

Recall number

Z-2286-2023

Status

Open, Classified

Initiated by the company

Jun 22, 2023

Posted by the FDA

Aug 3, 2023

Recalling firm

Scican Ltd.

Quantity

3 units

Product code

FLE

FDA submissions

K192910

Distribution

US Nationwide Distribution and in the country of Canada

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• STATCLAVE G4 Chamber Autoclave G4-622303

  Scican Ltd · Sterilizer, Steam
  1 recall0 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 92682).

• Z-2285-2023 · Open, Classified
  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