Device Recall Portable Oxygen System regulators: OxyTOTE, OxyTOTE 3000, OxyTOTE NG, OxyTOTE 3000 NG

  • Modèle / numéro de série
    The recall affects all lot numbers (made prior to 10/01/2014) for the following Model Numbers:  AAG-403; AAG-800; AAG-802; AAG-803; GTS-303; GTS-4206; GTS-600; GTS-603; JHR-900; JHR-LG-MTS-903; LAW-603; MNR-3000; MNR-600; MNR-800; MNS-602; MNS-603;; MNS-803; MNS-C803; MTR-100; MTR-300; MTR-500; MTR-600; MTR-700; MTR-800; MTS-303; MTS-403; MTS-501; MTS-502; MTS-503; MTS-505; MTS-601; MTS-602; MTS-603; MTS-803; OXC-503; PHS-LG-MTS-803; ROC-9792; ROC-9793; RRI-500; RRI-600; TRI-803; VLB-603; VLB-603H; VNG-600; VNG-603; VNG-800; and WOX-603.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- US, including the states of Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, and Wyoming; and, the countries of CANADA, CHILE, GERMANY, ISRAEL, LEBANON, MACAU, MEXICO, PUERTO RICO, and SINGAPORE.
  • Description du dispositif
    Various OxyTOTE Portable Oxygen System regulators, Valve Integrated Pressure Regulator, one unit per package. || Product Usage: || Used to dispense Oxygen at prescribed flow rates to patients for therapeutic purposes and is designed to provide mobility with a self-contained supply of Oxygen.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Western / Scott Fetzer Company, 875 Bassett Rd, Westlake OH 44145-1142
  • Source
    USFDA