Events

Recall of Device Recall C1160 Universal Flexible Processing Tray

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
    46753
  • Event Risk Class
    Class 2
  • Event Number
    Z-1190-2008
  • Event Initiated Date
    2008-02-19
  • Event Date Posted
    2008-08-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68222
  • 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
    tray for endoscope sterilizer - Product Code MED
  • Reason
    Failure to effectively sterilize: under certain conditions, the design/operation of the c1160 tray may compromise the ability of the system 1 processor to correctly assess the state of the high pressure pump during the sterile cycle. the l6 sensor fails to alarm when the high pressure pump is not working properly.
  • Action
    Steris sent an Urgent Safety Alert/Recall letter dated 2/8/2008, to all customers. The letter stated that any device sterilized in the C1160 Tray should not be used clinically prior to a completion of a successful diagnostic cycle. Until further notice, you must run a diagnostic cycle after each sterile cycle involving a C1160 tray or alternately you must discontinue use of these trays. Steris service technicians will schedule visits to correct the problem.

Device

Device Recall C1160 Universal Flexible Processing Tray
  • Model / Serial
    All codes
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution, including USA, Puerto Rico, Canada, and Japan.
  • Product Description
    Steris C1160 Universal Flexible Processing Tray, for use with STERIS SYSTEM 1 Processor, used for sterilization of flexible endoscopes.
  • Manufacturer
    Steris Corp

Manufacturer

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