The Recall Desk
HighFDA (Devices)·Z-0768-2013·Announced 2013-02-13

Oxus Portable Oxygen Concentrator Li-Ion Battery Recall

Oxus America is recalling 1,724 Li-Ion batteries for the RS-00400 Portable Oxygen Concentrator due to potential over-discharge damage to cells.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device (oxygen concentrator) where a defect (over-discharged cells) poses a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Oxus America, Inc. is recalling 1,724 Li-Ion batteries used in the Oxus Portable Oxygen Concentrator (POC), model RS-00400, also branded as Reliability Plus byDrive. The device is intended to deliver concentrated oxygen for adult patients with chronic pulmonary diseases.

The recall is due to past battery inventory storage conditions and deficiencies in the maintenance procedure, which made it possible for some batteries to be over-discharged to the point of damaging the cells. The affected units were distributed worldwide, including in the United States, Canada, the European Union, South Africa, Korea, and Brazil.

Consumers should check their battery serial numbers against the list provided in the official recall notice. If a battery is affected, users should contact Oxus America, Inc. for instructions on how to proceed.

The recalled product

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.
Manufacturer
Oxus America, Inc.
Category
Medical Device — Oxygen Concentrator
Hazard
Affected units
1,724

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed in 16 states:

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