PlainRecalls
FDA Devices Critical Class I Terminated

Emergency Transport Ventilator Oxylog 3000 Ventilator and Oxylog 3000 plus Ventilator Catalog Numbers: 2M86300/2M86965 and 5704813/5704831. Volume controlled and pressure-controlled emergency and transport ventilators.

Reported: February 10, 2016 Initiated: December 22, 2015 #Z-0692-2016

Product Description

Emergency Transport Ventilator Oxylog 3000 Ventilator and Oxylog 3000 plus Ventilator Catalog Numbers: 2M86300/2M86965 and 5704813/5704831. Volume controlled and pressure-controlled emergency and transport ventilators.

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.

Details

Recalling Firm
Draeger Medical, Inc.
Units Affected
402 units (314 - Oxylog 3000; 88 - Oxylog 3000 Plus)
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.
Location
Telford, PA

Frequently Asked Questions

What product was recalled?
Emergency Transport Ventilator Oxylog 3000 Ventilator and Oxylog 3000 plus Ventilator Catalog Numbers: 2M86300/2M86965 and 5704813/5704831. Volume controlled and pressure-controlled emergency and transport ventilators.. Recalled by Draeger Medical, Inc.. Units affected: 402 units (314 - Oxylog 3000; 88 - Oxylog 3000 Plus).
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 10, 2016. Severity: Critical. Recall number: Z-0692-2016.