PlainRecalls
FDA Devices Critical Class I Terminated

Oxylog 3000, Disposable Pediatric Patient Circuit, Catalog Number: 5704964 The VentStar Oxylog 3000F disposable pediatric patient breathing circuit is used with the Dr¿ger Oxylog 3000 and Oxylog 3000 plus Emergency Transport Ventilators.

Reported: August 10, 2016 Initiated: May 31, 2016 #Z-2215-2016

Product Description

Oxylog 3000, Disposable Pediatric Patient Circuit, Catalog Number: 5704964 The VentStar Oxylog 3000F disposable pediatric patient breathing circuit is used with the Dr¿ger Oxylog 3000 and Oxylog 3000 plus Emergency Transport Ventilators.

Reason for Recall

Isolated episodes of leakage at the check valve were found

Details

Recalling Firm
Draeger Medical, Inc.
Units Affected
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.
Location
Telford, PA

Frequently Asked Questions

What product was recalled?
Oxylog 3000, Disposable Pediatric Patient Circuit, Catalog Number: 5704964 The VentStar Oxylog 3000F disposable pediatric patient breathing circuit is used with the Dr¿ger Oxylog 3000 and Oxylog 3000 plus Emergency Transport Ventilators.. Recalled by Draeger Medical, Inc.. Units affected: 42,922 units worldwide (US distribution 1,530).
Why was this product recalled?
Isolated episodes of leakage at the check valve were found
Which agency issued this recall?
This recall was issued by the FDA Devices on August 10, 2016. Severity: Critical. Recall number: Z-2215-2016.