MEDICAL DEVICE RECALL NOTICE

January 31, 2015

ATTN: Regulatory Affairs Manager, Risk Manager, Hospital Administrator, OxyTOTE Distributor, OxyTOTE Wholesaler, Oxygen Service Provider, Health Care Provider

RE: Western/Scott Fetzer OxyTOTE products which include the following models: OxyTOTE, OxyTOTE 3000, OxyTOTE NG, OxyTOTE 3000 NG, AirTOTE, and oxyQuik Series Valve Integrated Pressure Regulators (VIPR), as well as private label versions of these products.

Dear Valued Customer:

Western/Scott Fetzer is implementing a voluntary recall for OxyTOTE / oxyQuik / AirTOTE products, including OxyTOTE, OxyTOTE 3000, OxyTOTE NG, OxyTOTE 3000 NG, AirTOTE, and oxyQuik Series Valve Integrated Pressure Regulators, and all private label versions of these products. Hereafter, they will be referred to as “OxyTOTE/oxyQuik/AirTOTE”.

Description of the Product –

The OxyTOTE/oxyQuik/AirTOTE family of Valve Integrated Pressure Regulators (VIPR’s) subject to this recall are those mounted on aluminum Oxygen cylinders and used to dispense Oxygen at prescribed flow rates to patients for therapeutic purposes. Those mounted to steel cylinders are not subject to this recall.

Description of the Problem –

Western has received reports of three ignition events resulting in serious injuries, including one fatality. These events occurred unexpectedly and without warning, although handling may have been a contributing factor. All three ignition events occurred in the time period from March 2014 to January 2015, and all three events occurred following the Oxygen cylinder refilling process, not during product use in a healthcare setting. Launched in 2004, Western has distributed approximately 280,000 OxyTOTE/oxyQuik/AirTOTE systems throughout the US and North America, and millions of fill cycles occur each year without incident. Based upon an analysis of the events, Western has concluded that OxyTOTE/oxyQuik/AirTOTE units manufactured with a certain type of cylinder sealing o-ring are more prone to this rare but serious type of event, and this recall will mitigate the risk of further occurrences.

All OxyTOTE/oxyQuik/AirTOTE units on aluminum cylinders manufactured prior to October 2014 are subject to this recall. Units manufactured from October 2014 to present are not subject to this recall.

Please take care to minimize any sudden impact to the cylinder or VIPR and refer to the safe handling practices as indicated in the Safety Advisory Bulletin sent out in October 2014.

Western’s primary concern is the safety of our customers. We thank you in advance for your cooperation and understanding in this matter and sincerely apologize for any inconvenience this action may cause.

For the complete Medical Device Recall Notice as a PDF, click here.