Retiro De Equipo (Recall) de PURE OXYGEN CONCENTRATOR, CHAD Drive

Recall

78883

Class 2

Z-0407-2018

2017-10-09

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160803

Post-market surveillance for pure stationary oxygen concentrators model chsooo and chsooos demonstrate an aggregate complaint/service rate greater than 35% for low oxygen purity (output oxygen below the published specification).

The firm initiated their recall by letter on 10/09/2017. The letter stated the following: "Actions to be Taken: Based on our distribution records, your firm has received one or more Pure Stationary Oxygen Concentrators. We respectfully request that you take the following actions: 1. Contact all patients and customers that currently have Pure Stationary Oxygen Concentrators in their homes or facilities and inform them of this recall. Retrieve the oxygen concentrators from their homes or facilities. 2. Destroy all Pure Stationary Oxygen Concentrator(s) in accordance with the following steps: a. Assure that the unit is not plugged into an electrical outlet. b. Cut the power cord of each oxygen concentrator. c. Take a digital photo of each oxygen concentrator that depicts both the power cord and the serial number of the depicted unit. Note that the serial number is located on a label on the back of the unit. d. Dispose of the oxygen concentrator in accordance with local ordinances. e. Record the serial number of each unit that is destroyed, sign and date the enclosed Recall Return Response Card. 3. Email or fax the completed response form and photos documenting destruction to: Email: lnovo4209@stericycle.com Fax: 1-877-497-2559 4. Sales of the Pure Stationary Oxygen Concentrator have been discontinued. Pure Stationary Oxygen Concentrators which have been destroyed will be replaced with a DeVilbiss 525DS Oxygen Concentrator in order to minimize any interruption in patient's supplemental oxygen therapy. 5. Pure Concentrators that have been returned to lnovo for repair will not be returned and will be replaced with a DeVilbiss 525DS Oxygen Concentrator. Other Information: Should you require any additional information about this recall action, please call 1-888-679-5132, Monday-Friday 8am-Spm Eastern."