Recall Z-0768-2013— Oxus America, Inc.

Name: FDA recall Z-0768-2013
Creator: U.S. Food and Drug Administration
Published: 2013-01-14

Class II · Terminated

Class II FDA medical device recall by Oxus America, Inc., initiated 2013-01-14, terminated 2013-07-17. It names one FDA 510(k) clearance: K020324. Product: 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.. 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..

Recalling firm: Oxus America, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-01-14
Terminated: 2013-07-17
Firm location: Rochester Hills, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K020324 — LIFESTYLE OXYGEN CONCENTRATORAirsep Corp.·cleared 2002-03-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.