Events

Recall of Device Recall AMSCO C and AMSCO 400 Steam Sterilizers

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
    70938
  • Event Risk Class
    Class 2
  • Event Number
    Z-1561-2015
  • Event Initiated Date
    2015-02-19
  • Event Date Posted
    2015-04-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-01-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135639
  • 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
    Steris has identified that the control board software in select amsco 400 and amsco c units will interrupt and cancel a processing cycle should the selected sterilizer shutdown time coincide with a processing cycle. this may result in a procedure delay.
  • Action
    On 3/9/2015, the firm sent Urgent Field Correction Notices, to their customers. The letter identified the affected product and gave a description of the problem. The letter states that the control software is being revised to ensure the utility shutdown feature will not interrupt an ongoing processing cycle. STERIS Field Representatives will contact customers to schedule installation of the new control board on affected units. Customers may direct questions regarding the issue to STERIS Customer Service at 1-800-548-4873; Marie LaFrance, Product Manager, at 440-392-7648, or their local sales representative.

Device

Device Recall AMSCO C and AMSCO 400 Steam Sterilizers
  • Model / Serial
    AMSCO 400 Units: Serial #'s: 030051501 - 033641440; AMSCO C Units: Serial #'s: R020051501 - R023641403.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US, including the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, I, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, & WY; and, the countries of Afghanistan, Canada, Japan, Kuwait, Mexico, Republic of Korea, & United Arab Emirates.
  • Product Description
    AMSCO C and AMSCO 400 Steam Sterilizers, STERIS Corporation. || AMSCO C Small Sterilizer, AMSCO 400 Small Sterilizer, AMSCO 400 Medium Sterilizer. || Designed for sterilization of heat and moisture-stable materials used in healthcare facilities.
  • 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