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Inovo, Inc recalls PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000S
Recalled January 31, 2018 · FDA recall Z-0407-2018 · Inovo
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). · FDA Class II
Units
13,140 units
Sold at
worldwide
Description
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).
Product
PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000S
Manufacturer(s)
Inovo, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →