Reported Jan 31, 2018 · Terminated
PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000S
Inovo, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Inovo, Inc · 401 Leonard Blvd N · Lehigh Acres, FL · 33971-6302
Is this the product you have?
- PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000S
- Lot codes and dates
- UDI #(s): 00814470020013 (model CHSOOO)
- and 00814470020006 (model CHSOOOS)All serial numbers
- Amount recalled
- 13,140 units
Why it was 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).
This product could cause temporary or reversible health problems — stop using it.
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