Emergency Transport Ventilator Oxylog 2000 Plus Ventilator Catalog Number: 5705080. Volume c...

FDA Recall #Z-0691-2016 — Class I — December 22, 2015

Recall #Z-0691-2016 Date: December 22, 2015 Classification: Class I Status: Terminated

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.

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