Events

Recall of Device Recall Century Medium Sterilizer

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Steris Corp.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    38031
  • Event Risk Class
    Class 2
  • Event Number
    Z-1193-2007
  • Event Initiated Date
    2007-03-22
  • Event Date Posted
    2007-08-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-09-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=52810
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    steam sterilizer - Product Code FLE
  • Reason
    The cables inside the pump conduit box may be exposed (not covered with wire nut and/or electrical tape) that could cause a potential electrical shock hazard.
  • Action
    By telephone 3/22/2007, customers were instructed to cease using the product and a service technician would be dispatched immediately to repair the unit.

Device

Device Recall Century Medium Sterilizer
  • Model / Serial
    Prevac Steam Sterilizer, Model #'s V-136H, V-148H, V-160H, SV-148H, V-1264 & V-1263& SFPP Steam Sterilizer, Model #'s P-148H & P-160H.   Code # B093934202, B093924204, B09324223, B093924225, B093924227, B093924229, B093924233, B093924244, B093924246, B093924248, B093924250, B093924286, B093924288, B093924296, B093924307, B093924309, B093924310, B093924434, B093924476, B093927301, B093927302, B093927322, B300903936
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Denmark, Belgium, Greece, India, and Russia.There are no Canadian accounts.
  • Product Description
    Amsco Century Medium Steam Sterilizer (26" x 37.5") (660 x 950mm).
  • Manufacturer
    Steris Corp

Manufacturer

Steris Corp
  • Manufacturer Address
    Steris Corp, 5960 Heisley Rd, Mentor OH 44060-1834
  • Source
    USFDA