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Serious recall: Injury is possible or has been reported. Take action promptly.

Scican Ltd. 2023-08-09 Health serious FDA
Health · FDA · Recall #FDA-Z-2285-2023

STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health… Recall

Issued August 9, 2023 · Scican Ltd.

In August 2023, Scican Ltd. recalled the STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health…, a serious health recall reported by the FDA.

Compiled by Maya Ellison, RecallCheckr

What this means for you

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.

What you should do

  1. 1 Stop using STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health… right away.
  2. 2 Set it aside where it won't be used by mistake.
  3. 3 Contact Scican Ltd. to arrange your voluntary. See the official notice below for contact details.
  4. 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):

Recall details

Brand
Scican Ltd.
Category
Health
Recall date
August 9, 2023
Units affected
Not reported
Sold at
US Nationwide Distribution and in the country of Canada
Recall number
FDA-Z-2285-2023
Made in
Canada
Issuing agency
FDA

In context

  • Scican Ltd. has 1 recall in our database.
  • We're tracking 3,576 Health recalls in our database.
  • This is the 903rd Health recall we've logged in 2023.
Read the official FDA notice

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