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

FDA Device Recall #Z-0768-2013 — Class II — January 14, 2013

Recall Summary

Recall Number Z-0768-2013
Classification Class II — Moderate risk
Date Initiated January 14, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Oxus America, Inc.
Location Rochester Hills, MI
Product Type Devices
Quantity 1724 total units

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.

Distribution Pattern

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.

Lot / Code Information

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.

Frequently Asked Questions

Contact your physician immediately if you use an electrical device or implant affected by this recall. For external devices (monitors, pumps), stop using the device and contact the manufacturer for a replacement. For implanted devices (pacemakers, ICDs), your cardiologist will assess whether you need device replacement surgery — the decision depends on how dependent you are on the device and the actual failure rate observed in the field. Do not attempt to repair or modify a recalled electrical medical device yourself. Monitor for any new or unusual symptoms and report them to your doctor.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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