Events

Recall of RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Smith & Nephew, 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
    69137
  • Event Risk Class
    Class 2
  • Event Number
    Z-2688-2014
  • Event Initiated Date
    2014-08-13
  • Event Date Posted
    2014-09-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-08-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129732
  • 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
    negative pressure wound therapy Powered suction pump - Product Code OMP
  • Reason
    Modification were made to the renasys ez npwt systems without a 510(k) or premarket approval notification.
  • Action
    All RENASYS EZ Products will be removed from the field and customers will be transitioned to other product. On August 13, 2014 the firm sent an "Urgent- Medical Device Removal RENASYS EZ" notification via FedEx overnight asking that the use of the RENASYS EZ should be immediately discontinued and the device should be returned to Smith & Nephew. If you have questions, please reach out to your Customer Care representative or call 1-800-876-1261 Monday through Friday, 8:00 AM to 6:00 PM, Eastern Time.

Device

RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ)
  • Model / Serial
    Model #'s 66800059, all lots since product launched 01/16/2009
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution- US (nationwide) including MA, MN, NY and Puerto Rico; Canada, Mexico, Dubai, Australia, Chile, Colombia, Germany, France, England, Spain, Italy, Norway, Hong Kong, Shanghai, New Zealand, South Africa, Singapore, Japan, Thailand and the Caribbean Islands.
  • Product Description
    RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) for patients who would benefit from a suction device particulary as the device may promote wound healing.
  • Manufacturer
    Smith & Nephew, Inc.

Manufacturer

Smith & Nephew, Inc.
  • Manufacturer Address
    Smith & Nephew, Inc., 970 Lake Carillon Dr, Ste 110, Saint Petersburg FL 33716-1130
  • Manufacturer Parent Company (2017)
    Smith & Nephew plc
  • Source
    USFDA