Events

Recall of V.A.C. GranuFoam Silver Dressing

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
    69368
  • Event Risk Class
    Class 2
  • Event Number
    Z-0070-2015
  • Event Initiated Date
    2014-09-18
  • Event Date Posted
    2014-10-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-07-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130310
  • 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
    A portion of the v.A.C. granufoam silver dressing m8275099/10 lot 50775977 was incorrectly manufactured with an incorrect expiry date on the sterile pouch. the correct expiry date of 2015-11 is on the case label, however the pouch label identifies the expiry date of 2016-11.
  • Action
    KCI will send a customer letter to each consignee notifying them of the issue, and to return the affected units.

Device

V.A.C. GranuFoam Silver Dressing
  • Model / Serial
    Lot Number 50775911
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The affected product was distributed to Mexico, Turkey, and United Arab Emirates only. The affected product was not distributed to the US.
  • Product Description
    V.A.C. GranuFoam Silver Large Dressing is barrier to bacterial penetration and may help reduce infection. Featuring SensaT.R.A.C. Technology REF M8275099/10 STERILE Single Use only Latex Free Rx Only.
  • Manufacturer
    KCI USA, Inc.

Manufacturer

KCI USA, Inc.