Events

Recall of C1140 Processing Container/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
    26151
  • Event Risk Class
    Class 2
  • Event Number
    Z-0830-03
  • Event Initiated Date
    2003-04-23
  • Event Date Posted
    2003-05-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-02-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27179
  • 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, Chemical - Product Code MLR
  • Reason
    The container flow port is inverted, which restricts the flow of sterilant to the endoscope and affects the sterilization process.
  • Action
    The firm notified their customers by telephone and letter on 4/23/2003.

Device

C1140 Processing Container/Tray
  • Model / Serial
    Serial Numbers: 203793 - 204362
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was shipped to end-users located nationwide and worldwide.
  • Product Description
    C1140 Flexible Endoscope Processing Container and Tray assembly.
  • Manufacturer
    Steris Corp

Manufacturer

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