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U.S. Department of Health and Human Services

Class 1 Device Recall Portable Oxygen System regulators: OxyTOTE, OxyTOTE 3000, OxyTOTE NG, OxyTOTE 3000 NG

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  Class 1 Device Recall Portable Oxygen System regulators: OxyTOTE, OxyTOTE 3000, OxyTOTE NG, OxyTOTE 3000 NG see related information
Date Initiated by Firm January 31, 2015
Date Posted July 20, 2015
Recall Status1 Terminated 3 on January 18, 2018
Recall Number Z-2069-2015
Recall Event ID 70163
Product Classification Regulator, pressure, gas cylinder - Product Code CAN
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.
Code Information 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.
Recalling Firm/
Manufacturer		 Western / Scott Fetzer Company
875 Bassett Rd
Westlake OH 44145-1142
For Additional Information Contact Recall Support Group
440-871-2160 Ext. 2103
Manufacturer 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.
FDA Determined
Cause 2		 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: recall@WesternEnterprises.com 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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