Events

Recall of Device Recall ElastoGel Wound Dressing & ElastoGel Plus Wound Dressing (with Tape)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Southwest Technologies 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
    35051
  • Event Risk Class
    Class 2
  • Event Number
    Z-0841-06
  • Event Initiated Date
    2006-03-27
  • Event Date Posted
    2006-05-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-12-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45195
  • 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
    Dressing, Wound, Drug - Product Code FRO
  • Reason
    The product is labeled as sterile and one of the lots failed sterility during the quarterly radiation dose audit.
  • Action
    Recall letters were sent to all direct accounts via certified mail on 3/27/2006. The consignees were requested to return any affected product on hand and if the product was further distributed, notify their customers.

Device

Device Recall ElastoGel Wound Dressing & ElastoGel Plus Wound Dressing (with Tape)
  • Model / Serial
    Elasto-Gel Plus, Product DR8050, Lot 111004A. Elasto-Gel, Product DR8000LV, Lot 110904A. Elasto-Gel, Product No. DR8000, Lot 102504A.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Product was distributed to direct accounts in the United States and Belgium.
  • Product Description
    Elasto-Gel Wound Dressings, 3 product codes: DR8050, DR 8000, and DR 8000LV (for foreign distribution only), 4'' x 4'', Sterile, each package contains 1 wound dressing, 5 packages per intermediate box, 20 intermediate boxes (100 pkgs) per case. The label shows the product is Manufactured by Southwest Technologies, Inc., North Kansas City, MO.
  • Manufacturer
    Southwest Technologies Inc

Manufacturer

Southwest Technologies Inc
  • Manufacturer Address
    Southwest Technologies Inc, 1746 E Levee St, N Kansas City MO 64116-4404
  • Source
    USFDA