Events

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

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Western / Scott Fetzer Company.

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
    70163
  • Event Risk Class
    Class 1
  • Event Number
    Z-2069-2015
  • Event Initiated Date
    2015-01-31
  • Event Date Posted
    2015-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-01-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132378
  • 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
    Regulator, pressure, gas cylinder - Product Code CAN
  • Reason
    The firm has become aware of the possibility of ignition and rupture (explosion) of a compressed gas oxygen cylinder, which can cause serious injury and/or death.
  • Action
    Western/Scott Fetzer sent an Urgent Medical Device Recall Notice notification dated January 31, 2015 to their customers via U.S. mail. The notification identified the affected product, problem and actions to be taken. The OxyTOTE/oxyQuik/AirTOTE Distributors and Oxygen Service Providers were instructed to: 1) Notify and provide the letter to all accounts/customers to which any OxyTOTE/oxyQuik/AirTOTE products have been distributed. Alternately, please provide a list of customers who received affected product and Western/Scott Fetzer will notify them on your behalf. 2) Referring to the instructions for OxyTOTE/oxyQuik/AirTOTE Users and User Facilities, follow up with each account/customer to ensure that they locate and identify all affected product and establish the number of units in their possession subject to the recall. 3) Contact Western/Scott Fetzer to schedule remediation for any affected OxyTOTE/oxyQuik/AirTOTE product included under this notice. We will begin scheduling product for remediation on February 17, 2015. 4) Please complete the Recall Acknowledgement and Receipt Form and return it to Western/Scott Fetzer as soon as complete responses are available. The OxyTOTE/oxyQuik/AirTOTE Users and User Facilities (Hospitals, Health Care Facilities, Health Care Service providers, etc.) were instructed to: 1) Locate and identify any OxyTOTE/oxyQuik/AirTOTE product in your possession. 2) Review the instructions to determine if the product IS or IS NOT marked and if remediation is needed. 3) Contact your OxyTOTE/oxyQuik/AirTOTE supplier or Medical Gas Provider directly to schedule the remediation of product in your possession. For questions or concerns regarding this notification, please visit the website for additional details or contact Western/Scott Fetzer: Website: www.westernenterprises.com/recall By Email: recall@WesternEnterprises.com By Phone: (800) 783-7890, extension 2516 By Fax: (440) 835-8283 By Mail: Recall Coordinator, Wester

Device

Device Recall Portable Oxygen System regulators: OxyTOTE, OxyTOTE 3000, OxyTOTE NG, OxyTOTE 3000 NG
  • Model / Serial
    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.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    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.
  • Product Description
    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
    Western / Scott Fetzer Company

Manufacturer

Western / Scott Fetzer Company
  • Manufacturer Address
    Western / Scott Fetzer Company, 875 Bassett Rd, Westlake OH 44145-1142
  • Source
    USFDA