Events

Recall of VisUAll

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
    62852
  • Event Risk Class
    Class 3
  • Event Number
    Z-2325-2012
  • Event Initiated Date
    2012-08-02
  • Event Date Posted
    2012-09-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-09-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111874
  • 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
    Indicator, sterilization - Product Code LRT
  • Reason
    On 7/20/2012 the firm became aware that a lot of tubing was distributed by the supplier after it was rejected by steris due to failing process indicators.
  • Action
    Steris sent a Urgent Voluntary Recall Notice letter dated August 2, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Steris has learned that the VIS-U-All tubing is not performing to product specifications. Upon receipt of replacement product we ask that you destroy any remaining inventory of the affected lot in your possession. In the interim period, should you receive a failing result following a sterilization cycle, the results must be handled in accordance with your internal hospital procedures. We apologize for any inconvenience this matter may cause you. For further questions please call 1-(800) 548-4873.

Device

VisUAll
  • Model / Serial
    Product code KCT; Lot number: 60263
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution--USA (nationwide) including the states of AL, AZ, CA, FL, IL, IN, KY, LA, MO, MS, NJ, OH, PA, SD, TX, and VA., and the countries of Japan, Peru, and Suriname.
  • Product Description
    100 ft roll of tubing inside a cardboard box. Medical devices are sealed into the tubes prior to ethylene oxide sterilization. Tube maintains sterility of the enclosed medical devices until opened.
  • 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