Events

Recall of Device Recall ActCel Topical Hemostatic Dressing

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Coreva Health Science LLC.

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
    71279
  • Event Risk Class
    Class 2
  • Event Number
    Z-1697-2015
  • Event Initiated Date
    2015-05-18
  • Event Date Posted
    2015-05-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-08-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137216
  • 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
    Coreva health science, llc. is recalling actcel hemostatic dressing due to customer literature and web sites promoting that it can help control bleeding from open wounds and in body cavities. actcel is indicated as a prescription device for management of topical wounds and to temporarily control external surface bleeding.
  • Action
    On 05/18/15 the firm sent out customer notification letters to those distributors that were identified as marketing ActCel Hemostatic Dressing for use to help control bleeding from open wounds in body cavities. The firm's notification letter provided the following actions to be taken by the customer: - Review their literature and labeling (including internet websites) to determine whether there are any marketing statements for usage in body cavities; -Destroy all hardcopy literature and labeling with the statement for usage in body cavities - Correct all Internet websites eliminating his statement; and - Complete the attached Medical Device Labeling Clarification Return Response form and return it to Coreva Health Science. The firm states to direct any questions to: Ms. Casssie Inglis, Vice President of Marketing. email: cassie@coreva.net phone: 818-685-0951 ext. 119 toll free: 800-808-9094 ext. 119 Monday through Friday, 9am-4pm PST

Device

Device Recall ActCel Topical Hemostatic Dressing
  • Model / Serial
    201303054, 201310418, 201406259, 201409367, 201502051, 201307297, 201310460, 201401023, 201406260, 201409368, 201303054, 201305137, 201401022, 201403096, 201404143
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    Unclassified
  • Implanted device?
    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.
  • Product Description
    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
    Coreva Health Science LLC

Manufacturer

Coreva Health Science LLC
  • Manufacturer Address
    Coreva Health Science LLC, 2985 E Hillcrest Dr Ste 205, Westlake Village CA 91362-3179
  • Manufacturer Parent Company (2017)
    Coreva Health Science Llc
  • Source
    USFDA