Events

Recall of Device Recall PRE1001US: Prevena Peel and Place System Kit (USONLY)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by KCI USA, 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
    67454
  • Event Risk Class
    Class 2
  • Event Number
    Z-1136-2014
  • Event Initiated Date
    2014-01-30
  • Event Date Posted
    2014-03-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-04-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125480
  • 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
    Prevena incisional management system kit/dressing connector - the male connector on the tubing is difficult to connect to the female connector on the prevena canister tubing.
  • Action
    KCL sent an Urgent Voluntary Medical Device Correction letter dated February 2014 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to locate, quarantine and return the affected device. For a replacement of the affected product and questions customers were instructed to contact KCL Customer Technical Support at 1-800-275-4524. A Product Reconciliation Form is attached to be completed and returned.

Device

Device Recall PRE1001US: Prevena Peel and Place System Kit (USONLY)
  • Model / Serial
    Kit Lot #'s 2363894, 2365884, 2367866, 2367891, 2367892, 2367893, 2367894, 2367900, 2376873, 2376874, 2376876, 2386885, 2397885, 2397886, 2397887, 2397888, 2398866, 2410934, 2410935, 2421871
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA Nationwide Distribution
  • Product Description
    PRE1001US: Prevena Peel and Place System Kit (US-ONLY) || Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.
  • Manufacturer
    KCI USA, INC.

Manufacturer

KCI USA, INC.