Emergency Transport Ventilator Oxylog 2000 Plus Ventilator Catalog Number: 5705080. Volume c...
FDA Recall #Z-0691-2016 — Class I — December 22, 2015
Product Description
Emergency Transport Ventilator Oxylog 2000 Plus Ventilator Catalog Number: 5705080. Volume controlled emergency and transport ventilator with pressure support.
Reason for Recall
Drager became aware of situations where the error message "Poti unplugged" was generated causing acoustic and visual alarms, the breathing system releases pressure and the ventilation function stops operating.
Recalling Firm
Draeger Medical, Inc. — Telford, PA
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Distribution
Nationwide Distribution -- including states of AR, AZ, CA, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY.
Code Information
All Oxylog 2000 plus Ventilators with the identified catalog numbers distributed between April 2007 - December 2015.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.