Recall Z-2286-2023— Scican Ltd.

Name: FDA recall Z-2286-2023
Creator: U.S. Food and Drug Administration
Published: 2023-06-22

Class II · Ongoing

Class II FDA medical device recall by Scican Ltd., initiated 2023-06-22. It names one FDA 510(k) clearance: K192910. 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 622303. 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..

Recalling firm: Scican Ltd.
Classification: Class II
Status: Ongoing
Initiated: 2023-06-22
Firm location: North York, N/A, Canada

510(k) clearances named in this recall

1 on FDA's record

K192910 — STATClave G4 Chamber AutoclaveScican , Ltd.·cleared 2020-06-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.