Events

Recall of Device Recall SKINPREP Protective wipes

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by BioDerm, 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
    68313
  • Event Risk Class
    Class 2
  • Event Number
    Z-1743-2014
  • Event Initiated Date
    2011-05-31
  • Event Date Posted
    2014-06-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-06-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127322
  • 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
    Bandage, liquid, skin protectant - Product Code NEC
  • Reason
    On 06/08/2011, bioderm, inc. issued a voluntary recall of a component skin wipes for the bioderm liberty 3.0 external male catheter, bioderm liberty pouch clean & dry external male catheter and bioderm safe n' dry. this component (wipes) were initially manufacturer by smith & nephew and recalled due to a potential bacterial contamination.
  • Action
    Notice was sent to customers by letter dated June 8, 2011 and by phone.

Device

Device Recall SKINPREP Protective wipes
  • Model / Serial
    Lot Codes: Range from U24401 through U29801;  Model Numbers: 23046, 23036, 21046, 21036. 21026 and 21006.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of AZ, CA, FL, NH, NJ, NY, PA, TX, and WI, and the countries of Canada and Netherlands.
  • Product Description
    BioDerm Liberty Pouch Clean & Dry External Male Catheter Specialty Type with integral collection chamber (Component: SKIN-PREP Protective wipes). || The recalled wipes are used on intact skin for applying skin protectant to the glands for control of male incontinence with an external, non-invasive and nonsterile device.
  • Manufacturer
    BioDerm, Inc.

Manufacturer

BioDerm, Inc.
  • Manufacturer Address
    BioDerm, Inc., 12320 73rd Ct, Largo FL 33773-3011
  • Manufacturer Parent Company (2017)
    Bioderm Inc.
  • Source
    USFDA