Device Recall ActCel Topical Hemostatic Dressing

  • Modèle / numéro de série
    201303054, 201310418, 201406259, 201409367, 201502051, 201307297, 201310460, 201401023, 201406260, 201409368, 201303054, 201305137, 201401022, 201403096, 201404143
  • Classification du dispositif
  • Classe de dispositif
    Unclassified
  • Dispositif implanté ?
    No
  • Distribution
    U.S. distribution to the following; TX, NY, FL, VA, WA, and AZ. No foreign distribution. NOTE: The distribution list the firm provided does not include all consignees that purchased the product; rather target the consignees (distributors) who were observed to be using an unapproved marketing use.
  • Description du dispositif
    ActCel || advanced bleeding control || Topical Hemostatic Dressing || 2in X 2in (5cm X 5cm) || 4in X 4in || Sterile Contents || Soluble Regenerated Cellulose || For Bleeding Control || For external topical and temporary use only || Sterility of contents guaranteed unless individual envelope is damaged or opened. Store at room temperature (41F-104F). Do not autoclave.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Coreva Health Science LLC, 2985 E Hillcrest Dr Ste 205, Westlake Village CA 91362-3179
  • Société-mère du fabricant (2017)
  • Source
    USFDA