Draeger Medical, Inc. recalls Oxylog 3000, Disposable Pediatric Patient Circuit, Catalog Number: 5704964 The VentStar Oxylog 3000F disposable pediatr…

Recall date

May 31, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2215-2016

FDA classification

Class I

Brand / firm

Draeger Medical, Inc.

Sold / distributed

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.

Why it was recalled

Isolated episodes of leakage at the check valve were found

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What 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.