Z-0018-2011

Oxylog 3000, Emergency and Transport Ventilator; Catalog #2M86300; Drager Medical Inc., 3135 Quarry Road...

Name: Z-0018-2011 Oxylog 3000, Emergency and Transport Ventilator; Catalog #2M86300; Drager Medical Inc., 3135 Quarry Road...
Creator: Draeger Medical Systems, Inc.
Published: 2010-08-19
License: https://open.fda.gov/license/

Draeger Medical Systems, Inc. / initiated 2010-08-19 / Terminated / root cause: labeling and UDI

FDA source

Draeger Medical Systems, Inc. began a recall of Oxylog 3000, Emergency and Transport Ventilator; Catalog #2M86300; Drager Medical Inc., 3135 Quarry Road, Telford, PA 18969 on 2010-08-19. The reason FDA records is "Patients received insufficient ventilation. The Oxylog 3000 Instructions are inadequate relating to dead space volume". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0018-2011
Status: Terminated
Initiated: 2010-08-19
Posted: 2010-10-07
Terminated: 2010-11-18
Recalling firm: Draeger Medical Systems, Inc.
Product: Oxylog 3000, Emergency and Transport Ventilator; Catalog #2M86300; Drager Medical Inc., 3135 Quarry Road, Telford, PA 18969.
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: Patients received insufficient ventilation. The Oxylog 3000 Instructions are inadequate relating to dead space volume.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: The firm sent Important Safety Notice Letter, dated August 2010, and Instructions for Use supplement to consignees. The letter explained the issue with the affected product. The letter asks customers to attach the Instructions for Use amendment sheet supplied with the letter to their corresponding Instructions for Use. The firm also states that a they will provide a dedicated pediatric breathing circuit for the Oxylog 3000. Questions regarding the letter should be directed to Michael Kelhart at 1-800-543-5047. Questions regarding the use of the device should be directed to DragerService Technical Support at 1-800-543-5047 or your local Drager Sales Representative.
Quantity in commerce: 78 potentially afftected units
Distribution: Nationwide Distribution
Product codes and lots: only units manufactured before 9/08

Product code CBK

K062267Class IIOxylog 3000Drager Medical B.V. / cleared 2006-10-31

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)