FDA recall Z-0407-2018

Product

PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000S

Reason for recall

Post-market surveillance for Pure Stationary Oxygen Concentrators model CHSOOO and CHSOOOS demonstrate an aggregate complaint/service rate greater than 35% for low oxygen purity (output oxygen below the published specification).

Distribution

worldwide

Key facts

Status

Terminated

Initiation date

2017-10-09

Report date

2018-01-31

Termination date

2023-09-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lehigh Acres, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0407-2018