Events

Recall of Device Recall Burn Sheet, sterile 60 x 96

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Certified Safety Mfg 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
    77593
  • Event Risk Class
    Class 2
  • Event Number
    Z-3078-2017
  • Event Initiated Date
    2017-06-26
  • 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=156722
  • 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
    Burn kit without drug - Product Code OJJ
  • Reason
    Burn sheet has possibility of being shredded.
  • Action
    Customers were notified via email on approximately 06/26/2017. Instructions included removing any affected burn sheets from first aid kits in stock, notify customers to do the same, return the response form and make arrangements for replacement items if necessary.

Device

Device Recall Burn Sheet, sterile 60 x 96
  • Model / Serial
    Burn Sheet: Dukal Part # 7305, 30-01, CSM Part # R505-091.   First Aid Kit: CSM Part # K608-061 36M.   Burn pad lot numbers: JT36112, JT09113, JT17513.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution in the states of KY, MD, NY, PA, VA
  • Product Description
    Burn Sheet, sterile - 60" x 96". Included in First Aid Kits: 36M - Delmarva Power/ACE - w/Logo, Certified Safety Manufacturing logo, and sold blank. || product Usage: || Provides sterile environment to protect patient from infection
  • Manufacturer
    Certified Safety Mfg Inc

Manufacturer

Certified Safety Mfg Inc
  • Manufacturer Address
    Certified Safety Mfg Inc, 1400 Chestnut Ave, Kansas City MO 64127-2023
  • Source
    USFDA