Various OxyTOTE Portable Oxygen System regulators recall
Various OxyTOTE Portable Oxygen System regulators, Valve Integrated Pressure Regulator, one unit per package. Product Usage: Used to dispense Oxygen…
Why was Various OxyTOTE Portable Oxygen System regulators recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Various OxyTOTE Portable Oxygen System regulators, Valve Integrated Pressure Regulator, one unit per package. Product Usage: Used to dispense Oxygen…
- Recalling firm
- Western / Scott Fetzer Company
- Quantity
- 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.
- Recall date
- July 29, 2015
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)