Z-0407-2018Class II

PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000S

Name: Z-0407-2018 PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000S
Creator: Inovo, Inc
Published: 2017-10-09
License: https://open.fda.gov/license/

Inovo Inc. / initiated 2017-10-09 / Terminated

FDA source

Inovo, Inc began a recall of PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000S on 2017-10-09. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0407-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-09
Posted: 2018-01-24
Terminated: 2023-09-15
Recalling firm: Inovo Inc.
Product: PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000S
Product code: CAW Generator, Oxygen, Portable
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).
FDA root cause: Under Investigation by firm
Action: The firm initiated their recall by letter on 10/09/2017. The letter stated the following: "Actions to be Taken: Based on our distribution records, your firm has received one or more Pure Stationary Oxygen Concentrators. We respectfully request that you take the following actions: 1. Contact all patients and customers that currently have Pure Stationary Oxygen Concentrators in their homes or facilities and inform them of this recall. Retrieve the oxygen concentrators from their homes or facilities. 2. Destroy all Pure Stationary Oxygen Concentrator(s) in accordance with the following steps: a. Assure that the unit is not plugged into an electrical outlet. b. Cut the power cord of each oxygen concentrator. c. Take a digital photo of each oxygen concentrator that depicts both the power cord and the serial number of the depicted unit. Note that the serial number is located on a label on the back of the unit. d. Dispose of the oxygen concentrator in accordance with local ordinances. e. Record the serial number of each unit that is destroyed, sign and date the enclosed Recall Return Response Card. 3. Email or fax the completed response form and photos documenting destruction to: Email: [email protected] Fax: 1-877-497-2559 4. Sales of the Pure Stationary Oxygen Concentrator have been discontinued. Pure Stationary Oxygen Concentrators which have been destroyed will be replaced with a DeVilbiss 525DS Oxygen Concentrator in order to minimize any interruption in patient's supplemental oxygen therapy. 5. Pure Concentrators that have been returned to lnovo for repair will not be returned and will be replaced with a DeVilbiss 525DS Oxygen Concentrator. Other Information: Should you require any additional information about this recall action, please call 1-888-679-5132, Monday-Friday 8am-Spm Eastern."
Quantity in commerce: 13,140 units
Distribution: worldwide
Product codes and lots: UDI #(s): 00814470020013 (model CHSOOO) and 00814470020006 (model CHSOOOS): All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0407-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0407-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-31	2018-01-24

Product code CAW

K080391Class IIDrive Solstice Oxygen ConcentratorMedical Depot / cleared 2008-03-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)