Z-2215-2016Class I

Oxylog 3000, Disposable Pediatric Patient Circuit, Catalog Number: 5704964 The VentStar Oxylog 3000F...

Name: Z-2215-2016 Oxylog 3000, Disposable Pediatric Patient Circuit, Catalog Number: 5704964 The VentStar Oxylog 3000F...
Creator: Draeger Medical, Inc.
Published: 2016-05-31
License: https://open.fda.gov/license/

Draeger, Inc. / initiated 2016-05-31 / Terminated / root cause: design

FDA source

Draeger Medical, Inc. began a recall of Oxylog 3000, Disposable Pediatric Patient Circuit, Catalog Number: 5704964 The VentStar Oxylog 3000F disposable pediatric patient breathing circuit is used... on 2016-05-31. FDA classified it as Class I and gives the reason as "Isolated episodes of leakage at the check valve were found". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2215-2016
Classification: Class I
Status: Terminated
Initiated: 2016-05-31
Posted: 2016-08-04
Terminated: 2018-03-14
Recalling firm: Draeger, Inc.
Product: Oxylog 3000, Disposable Pediatric Patient Circuit, Catalog Number: 5704964 The VentStar Oxylog 3000F disposable pediatric patient breathing circuit is used with the Drger Oxylog 3000 and Oxylog 3000 plus Emergency Transport Ventilators.
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: Isolated episodes of leakage at the check valve were found
Root cause tag: design
FDA root cause: Device Design
Action: Drager sent an Urgent Medical Device Recall letter dated May 31, 2016 and Customer Reply and Order Card to all customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to inspect stock and dispose of affected products. For questions regarding this letter 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 device/accessory contact DrgerService Technical Support at 1-800- 543-5047 (press 4 at the prompt).
Quantity in commerce: 42,922 units worldwide (US distribution 1,530)
Distribution: US Nationwide Distribution including states of: AK, CA, FL, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NY,OH,OK,OR,PA,TN,TX,UT,VA,WA, and WI.
Product codes and lots: Catalog Number: 5704964

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2215-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2215-2016	Class I	Terminated	Voluntary: Firm initiated	2016-08-10	2016-08-04

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)