Events

Recall of Device Recall ActiV.A.C. 300ml Canister (with Gel) for ActiV.A.C. Therapy System

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
    72753
  • Event Risk Class
    Class 2
  • Event Number
    Z-0600-2016
  • Event Initiated Date
    2015-11-25
  • Event Date Posted
    2016-01-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-11-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142133
  • 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
    There is potential for small holes, the size of a pin, to develop in the pouches of the activ.A.C. sterile canisters.
  • Action
    Customer notification letters were sent out the week of November, 23, 2015. The international distributors will be responsible for notification to their sub-consignees.

Device

Device Recall ActiV.A.C. 300ml Canister (with Gel) for ActiV.A.C. Therapy System
  • Model / Serial
    Models M8275058-JP/5 and M8275059/5. manufactured between October 5, 2014 and May 29, 2015. Labeled with a 23 month shelf life from the date of manufacture.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Japan and Australia
  • Product Description
    ActiV.A.C. 300ml Canister (with Gel) for ActiV.A.C. Therapy System for the application of V.A.C. Therapy in the acute extended and home care settings. The software-controlled therapy unit applies negative pressure wound therapy. The dressing, to which the therapy unit is connected, enables distribution of the negative pressure across the surface of the wound, while the tubing transfers accumulated fluids to the canister.
  • Manufacturer
    KCI USA, INC.

Manufacturer

KCI USA, INC.