Events

Recall of Device Recall Simpurity DermaPro Waterproof Silicone Tape, Safe'n'Simple, WOUNDCARE

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
    80234
  • Event Risk Class
    Class 2
  • Event Number
    Z-2229-2018
  • Event Initiated Date
    2017-12-14
  • 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=164922
  • 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
    Tape and bandage, adhesive - Product Code KGX
  • Reason
    The recalling firm received a customer complaint stating the tape was difficult to peel off the roll and had poor adhesion.
  • Action
    The recalling firm notified its distributors via phone call and email on January 3, 2018. The firm informed distributors of the issue with the affected product, and offered to replace affected product, and suggested replacing product distributed to customers.

Device

Device Recall Simpurity DermaPro Waterproof Silicone Tape, Safe'n'Simple, WOUNDCARE

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