Events

Recall of AMSCO

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

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
    72217
  • Event Risk Class
    Class 3
  • Event Number
    Z-0210-2016
  • Event Initiated Date
    2015-09-03
  • Event Date Posted
    2015-11-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-01-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140236
  • 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
    Sterilizer, steam - Product Code FLE
  • Reason
    In amsco small steam sterilizers equipped with the cs-iq feature, the sterilizer software inadvertently prevents the capability to operate the foot pedal, which allows the operator to open and close the sterilizer door.
  • Action
    On 9/21/2015 the firm sent Recall Correction Notices to their customers.

Device

AMSCO
  • Model / Serial
    Serial #'s: 033331205, 033341248, 033351210, 033401221, 033411215, 033451217, 030741306, 031491314, 032381302, 032341304, 033281222, 030621412, 030871412, 030871410, 031751401, 031771425, 031781412, 031781414, 031911436, R020141502, R020151501, R020191502, R020201501, R020261502, R020261504, R020271501, 030341514, R020471501, 030501540, 030651519, R021001503, R021051501
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US nationwide distribution.
  • Product Description
    AMSCO 400 and AMSCO C Small Steam Sterilizers
  • Manufacturer
    Steris Corporation

Manufacturer

Steris Corporation
  • Manufacturer Address
    Steris Corporation, 5960 Heisley Rd, Mentor OH 44060-1834
  • Manufacturer Parent Company (2017)
    Steris Corporation
  • Source
    USFDA