Z-0768-2013Class II

Li-Ion battery used in the Oxus Portable Oxygen Concentrator (POC), RS-00400. Also branded as Reliability...

Name: Z-0768-2013 Li-Ion battery used in the Oxus Portable Oxygen Concentrator (POC), RS-00400. Also branded as Reliability...
Creator: Oxus America, Inc.
Published: 2013-01-14
License: https://open.fda.gov/license/

Oxus America, Inc. / initiated 2013-01-14 / Terminated / root cause: manufacturing process

FDA source

Oxus America, Inc. began a recall of Li-Ion battery used in the Oxus Portable Oxygen Concentrator (POC), RS-00400. Also branded as Reliability Plus byDrive. The Portable Oxygen Concentrator is... on 2013-01-14. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0768-2013
Classification: Class II
Status: Terminated
Initiated: 2013-01-14
Posted: 2013-02-02
Terminated: 2013-07-17
Recalling firm: Oxus America, Inc.
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.
Product code: CAW Generator, Oxygen, Portable
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: part number RS-00402 Unit ID # (TS-): 001418, 001419, 001420, 001421, 001422, 001423, 001424, 001425, 001426, 001427, 001428, 001429, 001430, 001431, 001432, 001433, 001434, 001435, 001436, 001437, 001438, 001439, 001440, 001441, 001442, 001443, 001444, 001445, 001446, 001447, 001448, 001449, 001450, 001451, 001452, 001453, 001454, 001455, 001456, 001457, 001458, 001459, 001460, 001461, 001462, 001463, 001464, 001465, 001466, 001467, 001468, 001469, 001470, 001471, 001472, 001473, 001474, 001475, 001476, 001477, 001478, 001479, 001480, 001481, 001482, 001483, 001484, 001485, 001486, 001487, 001488, 001489, 001490, 001491, 001492, 001493, 001494, 001495, 001496, 001497, 001498, 001499, 001551, 001552, 001557, 001558, 001559, 001560, 001561, and 001562. Battery SN (MB-): 06625x, 06666x, 06679x, 06715x, 08335x, 06498x, 01578x, 12009x, 12010x, 00075x, 05624x, 11868x, 11855x, 11587x, 11601x, 08240x, 08336x, 06145x, 06160x, 06302x, 06305x, 08189x, 08190x, 09200x, 09562x, 09564x, 09654x, 09719x, 09720x, 09787x, 09788x, 09887x, 09902x, 09903x, 09904x, 09905x, 09906x, 09957x, 09958x, 09959x, 09960x, 09961x, 10049x, 10477x, 10478x, 10479x, 10480x, 05689x, 05690x, 05694x, 05695x, 05696x, 05727x, 07937x, 07938x, 07940x, 07941x, 08072x, 08112x, 08125x, 10358x, 11165x, 11166x, 11961x, 11027x, 08628x, 08630x, 09143x, 09144x, 09145x, 09146x, 09498x, 09888x, 09889x, 09890x, 09891x, 09983x, 09984x, 10547x, 10549x, 10550x, 01476x, 01527x, 01576x, 05630x, 08657x, 08677x, 08752x, 08753x, 08755x, 08838x, 09724x, 10237x, 10582x, 10597x, 10600x, 11252x, 11253x, 11264x, 11265x, 11266x, 11271x, 11272x, 11469x, 11472x, 11473x, 11525x, 11526x, 11527x, 11528x, 11999x, 01518x, 09212x, 10584x, 10602x, 11110x, 11426x, 11427x, 11456x, 11471x, 11478x, 11485x, 11486x, 11514x, 11518x, 11589x, 11591x, 11592x, 11593x, 05647x, 05648x, 05649x, 06646x, 06672x, 06673x, 06674x, 06675x, 06676x, 06702x, 07558x, 07637x, 07638x, 07639x, 07640x, 07641x, 07643x, 07644x, 07645x, 07663x, 07680x, 07689x, 07691x, 07697x, 07703x, 07704x, 07705x, 08257x, 08258x, 08259x, 08260x, 08649x, 08650x, 08681x, 08807x, 08808x, 08811x, 09304x, 09387x, 09388x, 09390x, 09859x, 09860x, 10089x, 10402x, 10613x, 10614x, 10616x, 05407x, 06072x, 06078x, 06080x, 06081x, 06209x, 06217x, 06226x, 06277x, 06278x, 06279x, 06299x, 06329x, 06331x, 06396x, 06432x, 06433x, 06434x, 06436x, 06442x, 06443x, 06444x, 06445x, 06446x, 06474x, 06475x, 06476x, 06481x, 06512x, 06515x, 06517x, 06518x, 06522x, 06525x, 06810x, 06872x, 06874x, 06877x, 07030x, 07112x, 07113x, 07114x, 07116x, 07154x, 07169x, 07170x, 07171x, 07173x, 07194x, 05589x, and 07749x.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0768-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0768-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-13	2013-02-02

Product code CAW

K020324Class IILifestyle Oxygen ConcentratorAirsep Corp. / cleared 2002-03-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)