FDAFDA · Food and drugs·Recall number Z-0407-2018
PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000S
Published January 31, 2018 · Recall initiated: October 9, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Inovo, Inc
- Distributor
- worldwide
- Lot
- UDI #(s): 00814470020013 (model CHSOOO) and 00814470020006 (model CHSOOOS): All serial numbers
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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