FDA recall Z-0514-2021

Product

Invacare PerfectO2 V Oxygen Concentrator- intended for patients with respiratory disorders requiring supplemental oxygen Model Numbers: IRC5PO2V (US), IRC5PO2VC (Canada), All World: IRC5PO2VAW, IRC5PO2VAWL2, IRC5PO2VAWL3, IRC5PO2VAWL4, IRC5PO2VAWL5

Reason for recall

Breakdown of the sound abatement washer, and metal on metal wear inside the Pressure Equalization (P.E.) valve assembly in the concentrator may lead to failure that can result in self-extinguishing fires or cap explosions.

Distribution

Worldwide distribution. US Nationwide, Canada, Australia, China, Germany, Guam, New Zealand, and Northern Mariana Islands

Key facts

Status

Terminated

Initiation date

2020-10-30

Report date

2020-12-09

Termination date

2024-12-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Elyria, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0514-2021