Events

Recall of V.A.C. ATS Wound Healing System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Kinetic Concepts, 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
    34310
  • Event Risk Class
    Class 3
  • Event Number
    Z-0379-06
  • Event Initiated Date
    2005-09-16
  • Event Date Posted
    2006-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-02-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43525
  • 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
    Apparatus, Suction, Ward Use, Portable, Ac-Powered - Product Code JCX
  • Reason
    Possible mislabeling of shipping cartons.
  • Action
    All hospitals and nursing homes contacted via letter and by phone.

Device

V.A.C. ATS Wound Healing System
  • Model / Serial
    Lot #08150506M
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product distributed nationwide to hospitals and nursing homes in the following states: AL, AZ, CA, CO, CT, FL, IL, IN, KY, MA, NC, NY, OK, PA, SC, and TX.
  • Product Description
    V.A.C. ATS Canister with Gel (500 mL), Part #M6275063/10.S, distributed by Kinetic Concepts, Inc., San Antonio, TX. Product is labeled as STERILE.
  • Manufacturer
    Kinetic Concepts, Inc

Manufacturer

Kinetic Concepts, Inc
  • Manufacturer Address
    Kinetic Concepts, Inc, 4958 Stout Dr, San Antonio TX 78219-4334
  • Source
    USFDA