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
  • 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
  • 1 Event

Manufacturer

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