Device Recall Portex

  • Model / Serial
    Lot Numbers: 101219, 103102, 105025, 106337, 109045, 110699, 111198, K110057, K110924, K124484, K128817, K132629, K141382, K144904, K147200, K148053, K157883, K160686, K163440, K189808, K211510, K221874, K511628 4950-17
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    4950-16 Portex¿ Epidural Mini-pack
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Smiths Medical ASD, Inc., 10 Bowman Dr, Keene NH 03431-5043
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

117 devices with a similar name

Learn more about the data here

  • Model / Serial
    Lot # 1579258
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- including states of New York, Texas, Ohio, Utah, Alabama, Arizona, Kentucky, & Wyoming.
  • Product Description
    Portex Continuous Epidural Tray, Reference 4037-20 || An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anesthesia.
  • Manufacturer
  • Model / Serial
    Product manufactured before September 2009 and within its expiration date.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United States, Andorra, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Barbados, Belgium, Bermuda, Borneo, Brazil, Brunei, Bulgaria, Canada, Chile, China, C¿¿te d'Ivoire, Czech Republic, Denmark, East Timor, Egypt, Estonia, Finland, France, Georgia, Germany, Gibraltar, Greece, Guatemala, Vatican City, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Lebanon, Libya, Liechtenstein, Lithuania, Luxembourg, Malaysia, Maldives, Malta, Mexico, New Zealand, Netherlands, Norway, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Senegal, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Suriname, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom and Uruguay.
  • Product Description
    Portex¿ Uncuffed Paediatric Sized Tracheal Tube || Oral Nasal, Ivory 3.5 mm, || Product Code: 100/105/035. || Intended for oral and/or nasal intubation for airway management.
  • Manufacturer
  • Model / Serial
    Product manufactured before September 2009 and within its expiration date.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United States, Andorra, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Barbados, Belgium, Bermuda, Borneo, Brazil, Brunei, Bulgaria, Canada, Chile, China, C¿¿te d'Ivoire, Czech Republic, Denmark, East Timor, Egypt, Estonia, Finland, France, Georgia, Germany, Gibraltar, Greece, Guatemala, Vatican City, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Lebanon, Libya, Liechtenstein, Lithuania, Luxembourg, Malaysia, Maldives, Malta, Mexico, New Zealand, Netherlands, Norway, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Senegal, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Suriname, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom and Uruguay.
  • Product Description
    Portex¿ Tracheal Tube, Oral/Nasal, Murphy Eye, Clear, 3.5 mm || Product Code: 100/127/035. || Intended for oral and/or nasal intubation for airway management.
  • Manufacturer
  • Model / Serial
    Product manufactured before September 2009 and within its expiration date.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United States, Andorra, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Barbados, Belgium, Bermuda, Borneo, Brazil, Brunei, Bulgaria, Canada, Chile, China, C¿¿te d'Ivoire, Czech Republic, Denmark, East Timor, Egypt, Estonia, Finland, France, Georgia, Germany, Gibraltar, Greece, Guatemala, Vatican City, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Lebanon, Libya, Liechtenstein, Lithuania, Luxembourg, Malaysia, Maldives, Malta, Mexico, New Zealand, Netherlands, Norway, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Senegal, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Suriname, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom and Uruguay.
  • Product Description
    Portex¿ Polar Preformed Tracheal Tube, South Oral, Murphy Eye, Clear 3.5 mm || Product Code: 100/134/035. || Intended for oral and/or nasal intubation for airway management.
  • Manufacturer
  • Model / Serial
    Lot Numbers:  09-31  09-33  09-37  09-46  09-48  09-49  10-05  10-08  10-11  10-17
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of United Arab Emirates, Armenia, Brazil, Canada, France, Hungary, Italy, Jordan, Japan, Libya, Poland, Russian Federation, and Saudi Arabia.
  • Product Description
    First Breath ¿ Adult Oxygen Mask with Tubing, 213cm (7ft) || Reorder Number: 001421 || Oxygen/Aerosol Mask For acute use, e.g. Post-op recovery, minimal trauma, patient transfer; used for patients requiring more oxygen than is delivered via a standard nasal cannula (>6L/minute). During inspiration, the patient draws gases both from the oxygen flowing into the mask through the tubing as well as the room via ports on the sides of the mask. Oxygen concentration delivered is 40 60% depending on the patients breathing rate and tidal volume
  • Manufacturer
112 more