PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000S
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI #(s): 00814470020013 (model CHSOOO) and 00814470020006 (model CHSOOOS): All serial numbers
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Inovo, Inc
- 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).
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000S
Product Codes/Lot Numbers:
UDI #(s): 00814470020013 (model CHSOOO) and 00814470020006 (model CHSOOOS): All serial numbers
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0407-2018
Related Recalls
Class I - Dangerous
The pressure gauge (manometer) may dislodge from the threaded insertion/mount, creating a leak.
Class I - Dangerous
Device can fail during operation.