Z-0248-2020Class II

SAROS Oxygen System Model 3000

Name: Z-0248-2020 SAROS Oxygen System Model 3000
Creator: Caire, Inc.
Published: 2019-09-16
License: https://open.fda.gov/license/

Caire, Inc. / initiated 2019-09-16 / Terminated / root cause: manufacturing process

FDA source

Caire, Inc. began a recall of SAROS Oxygen System Model 3000 on 2019-09-16. FDA classified it as Class II and gives the reason as "There is an electronics control issue that causes the unit to not power on with battery power only". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0248-2020
Classification: Class II
Status: Terminated
Initiated: 2019-09-16
Posted: 2019-10-30
Terminated: 2020-12-16
Recalling firm: Caire, Inc.
Product: SAROS Oxygen System Model 3000
Product code: CAW Generator, Oxygen, Portable
Reason for recall: There is an electronics control issue that causes the unit to not power on with battery power only.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm initiated the recall by email on 09/16/2019. The firm explained the issue and requested the return of the units.
Quantity in commerce: 10 units
Distribution: US and Chile
Product codes and lots: Serial Numbers: CBB0817510005, CBB0817510003, CBB0817510004, CBB0817480515, CBB0817460330, CBB0818281053, CBB0817510001, CBB0817510002, CBB0818330784, CBB0818281052

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0248-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0248-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-06	2019-10-30

Product code CAW

K083163Class IIOmni 2 Oxygen SystemSequal Technologies, Inc. / cleared 2009-10-20

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)