FDA-Device2016-08-10Class I
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.
Draeger Medical, Inc.
Hazard
Isolated episodes of leakage at the check valve were found
Sold states
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.
Affected count
42,922 units worldwide (US distribution 1,530)
Manufactured in
3135 Quarry Rd, Telford, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2215-2016Don't want to check this manually?
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