Device Recall NonRebreather, Oxygen Mask

  • Model / Serial
    Lot Number (Product Code 3108-E) 100132, 104079, 105936; (Product Code 3108MM) 103715; (Product Code 86-106E) 100056, 101452, 101725, 102695, 103006, 104041, 104198, 104634, 104969, 105687; (Product Code 86-108E) 100057, 100200, 101453, 101726, 102080, 102477, 102566, 102696, 103005, 103549, 104042, 104199, 104450, 104694, 104847, 104971, 105596, 105688; (Product Code LM-86-106) 100138, 102215, 102866, 104160, 105169; (Product Code PMD06002) 100551; (Product Code PMD06003) 100550
  • 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 7 (2.1 m) Tubing, Product Code 3108-E, Product Code 3108MM, Product Code 86-106E, Product Code 86-108-E, Product Code LM-86-106, Product Code PMD06002, Product Code PMD06003
  • Manufacturer
  • 1 Event

Manufacturer

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