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.

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