Events

Recall of Device Recall Safe N Simple NoSting Skin Barrier Film

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Safe N Simple, 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
    80232
  • Event Risk Class
    Class 2
  • Event Number
    Z-2330-2018
  • Event Initiated Date
    2012-06-18
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164916
  • 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
    The firm received a customer complaint of observed spots on the wipes. the manufacturer confirmed that the product had bacterial contamination. this leads to a potential risk of infection.
  • Action
    On June 18, 2012, the firm disseminated "Important-Action Required" recall information to affected distributors via email or phone call. The notification requested all distributors to immediately stop selling the product. The following instructions were provided: 1. Quantity on hand should be emailed to safen'simple customer service manager, Michelle Bliszack, mbliszack@snsmedicalwipes.com. We would like to know the current quantity you have in inventory of the subject product by Tuesday, June 19th, 2012. 2. We request the product with lot number 20120115 be either discarded or returned back to safen'simple. We will arrange and pay for shipment back to our warehouse. safen'simple will replace all existing stock of lot number 20120115 at no charge with a new lot number. 3. Until we ship replacement product, appropriate substitutes in performance are products SNS80725 and SNS80744. They are both similar product, however the size of the wipe is smaller. Packaging is 25 wipes/box and 100 wipes/box respectively.

Device

Device Recall Safe N Simple NoSting Skin Barrier Film
  • Model / Serial
    20120115
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributors in CA, FL, OH, MI, NJ, NY, PA, TX, and VA.
  • Product Description
    Safe N Simple No-Sting Skin Barrier Film, Ostomy Skin Barrier Wipe, SNS00807
  • Manufacturer
    Safe N Simple, LLC

Manufacturer

Safe N Simple, LLC
  • Manufacturer Address
    Safe N Simple, LLC, 5827 Terex, Clarkston MI 48346-1717
  • Manufacturer Parent Company (2017)
    Safe N Simple Llc
  • Source
    USFDA