Z-2069-2015Class I

Various OxyTOTE Portable Oxygen System regulators, Valve Integrated Pressure Regulator, one unit per package

Name: Z-2069-2015 Various OxyTOTE Portable Oxygen System regulators, Valve Integrated Pressure Regulator, one unit per package
Creator: Western / Scott Fetzer Company
Published: 2015-01-31
License: https://open.fda.gov/license/

Western Enterprises, Inc. / initiated 2015-01-31 / Terminated / root cause: design

FDA source

Western / Scott Fetzer Company began a recall of Various OxyTOTE Portable Oxygen System regulators, Valve Integrated Pressure Regulator, one unit per package. Product Usage: Used to dispense Oxygen at... on 2015-01-31. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2069-2015
Classification: Class I
Status: Terminated
Initiated: 2015-01-31
Posted: 2015-07-20
Terminated: 2018-01-18
Recalling firm: Western Enterprises, Inc.
Product: 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.
Product code: CAN Regulator, Pressure, Gas Cylinder
Reason for recall: 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.
Root cause tag: design
FDA root cause: Component design/selection
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: [email protected] By Phone: (800) 783-7890, extension 2516 By Fax: (440) 835-8283 By Mail: Recall Coordinator, Wester
Quantity in commerce: 162,678 units
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 codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2069-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2069-2015	Class I	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-20

Product code CAN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)