Recall Z-0768-2013 ยท CAW Generator, Oxygen, Portable
Oxus America, Inc.
Li-Ion battery used in the Oxus Portable Oxygen Concentrator (POC), RS-00400. Also branded as Reliability Plus byDrive. The Portable Oxygen Concentrator is intended to deliver concentrated oxygen for adult patients with chronic pulmonary diseases.
| Date | Feb 2, 2013 (initiated Jan 14, 2013) |
| Status | Terminated |
| Reason | Due to past battery inventory storage conditions and deficiencies in the maintenance procedure, it was possible that some batteries were over-discharged to point of damaging the cells. |
| Root cause | Nonconforming Material/Component |
| Action | Oxus, Inc. sent an "URGENT: MEDICAL DEVICE RECALL" letter dated January 11, 2013 to all affected customers.The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 1-888-475-1568 for information related to this recall. |
| Quantity | 1724 total units |
| Distribution | Worldwide Distribution-USA including the states of New York, Michigan, Colorado, Texas, Iowa, Florida, Georgia, Ohio, Wisconsin, Oregon, Alabama, Illinois, Utah, Oklahoma, West Virginia and California and the countries of Canada, European Union, South Africa, Korea and Brazil. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020324 | LIFESTYLE OXYGEN CONCENTRATOR Airsep Corp., Mar 13, 2002 |