Events

Recall of ProVision Barrier Universal Hood/Gown; product 5431-33-000

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Depuy Orthopaedics, Inc..

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
    26691
  • Event Risk Class
    Class 2
  • Event Number
    Z-1042-03
  • Event Initiated Date
    2003-06-27
  • Event Date Posted
    2003-07-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-02-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28177
  • 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
    Gown, Surgical - Product Code FYA
  • Reason
    Lack of assurance of sterility, due to the possibility of an incomplete package seal.
  • Action
    An Urgent Recall Notice was sent to customers on June 27, 2003 via federal express. Customers were instructed to locate all affected inventory and to immediately return it to Depuy.

Device

ProVision Barrier Universal Hood/Gown; product 5431-33-000
  • Model / Serial
    All product manufactured between February 1, 2002 and June 17, 2003 that does not have a green square on the label above the CE mark. Product bearing the green square on the label has been 100% inspected and is not under recall.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    United States, Australia, Canada, Chile, England, India, Japan, Malaysia, Singapore, South Africa, Taiwan and United Kingdom
  • Product Description
    ProVision Barrier Universal Hood/Gown; product 5431-33-000
  • Manufacturer
    Depuy Orthopaedics, Inc.

Manufacturer

Depuy Orthopaedics, Inc.
  • Manufacturer Address
    Depuy Orthopaedics, Inc., 700 Orthopaedic Drive, Warsaw IN 46581
  • Source
    USFDA