Events

Recall of Device Recall Volcano R100 Sterile Equipment Cover

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Volcano 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
    73254
  • Event Risk Class
    Class 2
  • Event Number
    Z-1041-2016
  • Event Initiated Date
    2016-02-05
  • Event Date Posted
    2016-03-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143630
  • 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
    Drape, surgical - Product Code KKX
  • Reason
    Volcano corporation has identified that certain lot numbers of volcano r-100 sterile equipment covers may have the incorrect expiry date on the outer shipping box; individually wrapped inner product bears the correct expiry date.
  • Action
    Urgent Medical Device letters were sent to affected consignees the week of February 8, 2016 by Fed Ex or UPS so delivery can be tracked. For OUS consignees, the same letter will be sent and they will execute delivery to customers and track responses.

Device

Device Recall Volcano R100 Sterile Equipment Cover
  • Model / Serial
    REF numbers: PBKGB and PBKBG-10 (10 pack): all lots
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed US (nationwide) and the countries of Australia, South Africa, Canada, New Zealand, Belgium, Japan, and Paraguay.
  • Product Description
    Volcano R100 Sterile Equipment Cover; Sterile; || General Hospital: These Sterile Equipment covers are provided to cover equipment that is mean to be used in the sterile surgical field but cannot be sterilized. The sterile drapes are put over this equipment in case any sterile items may come into contact with them.
  • Manufacturer
    Volcano Corporation

Manufacturer

Volcano Corporation
  • Manufacturer Address
    Volcano Corporation, 2870 Kilgore Rd, Rancho Cordova CA 95670-6133
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA