Events

Recall of Device Recall NonRebreather Oxygen Mask, Pediatric with Tubing

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by ConvaTec, 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
    77282
  • Event Risk Class
    Class 2
  • Event Number
    Z-2243-2017
  • Event Initiated Date
    2017-05-10
  • Event Date Posted
    2017-05-24
  • 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=155621
  • 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
    Mask, oxygen - Product Code BYG
  • Action
    Recall Letters were sent to consignees on May 10, 2017. The letter requested that they immediately stop distribution and quarantine all affected lots. The letter also requested a sub-recall if the product had been further distributed. Also attached to the letter is a Recall Response Form to be returned.

Device

Device Recall NonRebreather Oxygen Mask, Pediatric with Tubing
  • Model / Serial
    Lot Number (Product Code 86-3226E) 100050, 100196, 102698, 103003, 104062, 104331, 104424, 104928, 105597; (Product Code PMD06009) 100574; (Product Code PMD06106) 100581
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    CA, CT, FL, GA, IL, MO, NJ, NY, NC, OH, PA, RI, VA , Puerto Rico, Australia, Belgium, Canada, Columbia, Czech, Denmark, Finland, France, Germany, Greece, Israel, Italy, Japan, Jordan, Malaysia, Malta, Netherlands, Norway, Rwanda, Saudi Arabia, Sweden, Switzerland, United Kingdom, and Vietnam
  • Product Description
    Non-Rebreather Oxygen Mask, Pediatric with Tubing, Product Code 86-3226E, Product Code PMD06009, Product Code PMD06106
  • Manufacturer
    ConvaTec, Inc

Manufacturer

ConvaTec, Inc
  • Manufacturer Address
    ConvaTec, Inc, 7900 Triad Center Dr Ste 400, Greensboro NC 27409-9076
  • Manufacturer Parent Company (2017)
    Triona Holding Sa
  • Source
    USFDA