Device Recall NonRebreather Oxygen Mask

  • Model / Serial
    Lot Number 100281, 100709, 100729, 101923, 103180, 103265, 103691, 103714, 104104, 105987, 110558
  • Product Classification
  • 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, Adult High Concentration with 2.1 m (7) Oxygen Tubing, Product Code 108MM
  • Manufacturer
  • 1 Event

Manufacturer

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

One device with a similar name

Learn more about the data here

  • 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
  • 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