Pure Oxygen Concentrator recall
PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000S
Why was Pure Oxygen Concentrator recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI #(s): 00814470020013 (model CHSOOO) and 00814470020006 (model CHSOOOS): All serial numbers
- Product
- PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000S
- Recalling firm
- Inovo, Inc
- Quantity
- 13,140 units
- Distribution
- worldwide
- Recall date
- January 31, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)