Home / Recalls / Inovo, Inc / Z-0407-2018

Z-0407-2018 Class II Terminated

Recalled by Inovo, Inc — Lehigh Acres, FL

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