FDAOctober 9, 2017device

PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000S

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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).

What to do

FDA enforcement status: Terminated

Brands named

inovo

UPCs

0081447002001300814470020006

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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