Z-0407-2018 Class II Terminated
FDA device recall Z-0407-2018 was initiated by Inovo, Inc on October 9, 2017 and is designated Class II. 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 recall status is terminated (terminated September 15, 2023). Affected quantity: 13,140 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 31, 2018
- Initiation Date
- October 9, 2017
- Termination Date
- September 15, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13,140 units
Product Description
PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000S
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).
Distribution Pattern
worldwide
Code Information
UDI #(s): 00814470020013 (model CHSOOO) and 00814470020006 (model CHSOOOS): All serial numbers