Events

Recall of Device Recall FROWound cleanser/ Dressing, wound, drug

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Oculus Innovative Sciences, 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
    75770
  • Event Risk Class
    Class 2
  • Event Number
    Z-0763-2017
  • Event Initiated Date
    2016-11-21
  • Event Date Posted
    2016-12-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-06-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151214
  • 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
    Firm became aware that professional samples of ceramax are not meeting stability standards set for the product.
  • Action
    Oculus issued Medical Device Recall letters dated November 21, 2016, to Sales reps notifying them to stop all further distribution and immediately remove the affected lots of Recall product from sample inventory. Customers were also instructed to sign the Response form verifying receipt of the letter. Customers with questions were instructed to call Oculus Innovative Science-Regulatory Affairs at 707-559-7181. For questions regarding this recall call 559-7191.

Device

Device Recall FROWound cleanser/ Dressing, wound, drug
  • Model / Serial
    Lot 3045639, expiration date: 01/2018
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Ceramax Skin Barrier Cream: || NET WT 0.1 OZ (3 g professional sample - not for retail sale) || Under the supervision of a health care professional, Ceramax is intended to be used as a topical skin care preparation to relieve and to manage the burning and itching associated with various dermatoses including atopic dermatitis, irritant contact dermatitis, radiation dermatitis, and other dry skin conditions, by maintaining a moist wound and skin environment. || General and Plastic Surgery: Ceramax is intended to be used as a topical skin care preparation to relieve and to manage the burning and itching associated with various dermatoses including atopic dermatitis, irritant contact dermatitis, radiation dermatitis, and other dry skin conditions, by maintaining a moist wound and skin environment.
  • Manufacturer
    Oculus Innovative Sciences, Inc.

Manufacturer

Oculus Innovative Sciences, Inc.
  • Manufacturer Address
    Oculus Innovative Sciences, Inc., 1129 N McDowell Blvd, Petaluma CA 94954-1110
  • Manufacturer Parent Company (2017)
    Sonoma Pharmaceuticals Inc.
  • Source
    USFDA