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U.S. Department of Health and Human Services

Class 1 Device Recall Emergency Transport Ventilator

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 Class 1 Device Recall Emergency Transport Ventilator see related information
Recall Date February 03, 2016
Recall Status1 Open
Recall Number Z-0692-2016
Recall Event ID 72914
510(K)Number K082600  K062267  K103625 
Product Classification Ventilator, continuous, facility use - Product Code CBK
Product 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.
Code Information All Oxylog 3000 Ventilators and Oxylog 3000 Plus Ventilators with the identified catalog numbers distributed between April 2007 - December 2015.
Recalling Firm/
Manufacturer
Draeger Medical, Inc.
3135 Quarry Rd
Telford PA 18969-1042
For Additional Information Contact
215-721-5400
Manufacturer 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.
FDA Determined
Cause 2
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, please contact Michael Kelhart at 1-800-543-5047 (press 1 at the prompt, then 2, then 32349). For questions regarding the operation and/or servicing of your Dr¿ger Oxylog ventilator please contact Dr¿gerService Technical Support at 1-800-543-5047 (press 4 at the prompt).
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = CBK and Original Applicant = DRAEGER MEDICAL B.V.
510(K)s with Product Code = CBK and Original Applicant = Draeger Medical Systems, Inc.
510(K)s with Product Code = CBK and Original Applicant = DRAGER MEDICAL B.V.
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