Z-1440-2014Class I

Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator. Part number: 5704833

Name: Z-1440-2014 Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator. Part number: 5704833
Creator: Draeger Medical Systems, Inc.
Published: 2014-03-05
License: https://open.fda.gov/license/

Draeger Medical Systems, Inc. / initiated 2014-03-05 / Terminated / root cause: manufacturing process

FDA source

Draeger Medical Systems, Inc. began a recall of Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator. Part number: 5704833 on 2014-03-05. FDA classified it as Class I and gives the reason as "The potentiometers (knobs) for setting the ventilation parameters may have contact interrupted and the device discontinues ventilation, gives an audible alarm and displays the error message Poti unplugged". 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-1440-2014
Classification: Class I
Status: Terminated
Initiated: 2014-03-05
Posted: 2014-04-10
Terminated: 2014-10-31
Recalling firm: Draeger Medical Systems, Inc.
Product: Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator. Part number: 5704833
Product code: BTL Ventilator, Emergency, Powered (Resuscitator)
Reason for recall: The potentiometers (knobs) for setting the ventilation parameters may have contact interrupted and the device discontinues ventilation, gives an audible alarm and displays the error message Poti unplugged.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Drager sent an Urgent Medical Device Recall letter dated February 2014 to affected customers. The letter identified the affected device, problem and actions to be taken. The notification directed customers to perform manual ventilation in the event of a failure. Drager plans to repair the affected devices free of charge. If you have any questions regarding the Recall letter please call 1-800-543-5047 (press 1 at the prompt, then 2, then 32349). For questions regarding the operation and/or servicing of your Drger ventilator please contact DrgerService Technical Support at 1-800-543-5047 (press 4 at the prompt).
Quantity in commerce: 3
Distribution: USA Nationwide Distribution in the states of WI and NY.
Product codes and lots: Oxylog 3000 plus, Part number: 5704833 with serial numbers: ASEK-0003, ASEK-0004, ASEK-0005

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1440-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1440-2014	Class I	Terminated	Voluntary: Firm initiated	2014-04-16	2014-04-10

Product code BTL

K103625Class IIOxylog 3000 Plus Workstation, Oxylog 3000 Plus Basic DeviceDraeger Medical Systems, Inc. / cleared 2011-10-06

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)