Recall Z-0692-2016 ยท CBK Ventilator, Continuous, Facility Use
Draeger Medical, Inc.
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.
| Date | Feb 3, 2016 (initiated Dec 22, 2015) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | The firm, Draeger Medical, Inc., sent an "Urgent Medical Device Recall" letter dated 12/21/2015 and a copy of the Instructions for Use (IFU) Supplement to consignees in a method that confirms delivery. The letter described the product, problem and actions to be taken. The consignees were instructed to include a copy of the supplement with their Oxylog IFU; inform all affected users in their facility; and contact Draeger Customer Support at 1-800-543-5047 (press 4 at the prompt) to obtain additional copies of the IFU Supplement Free of Charge. If there are any questions regarding this letter, |
| Quantity | 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. |
| FDA record | Open on fda.gov |