Date Initiated by Firm | March 05, 2014 |
Date Posted | April 10, 2014 |
Recall Status1 |
Terminated 3 on October 31, 2014 |
Recall Number | Z-1440-2014 |
Recall Event ID |
67677 |
510(K)Number | K103625 |
Product Classification |
Ventilator, emergency, powered (resuscitator) - Product Code BTL
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Product | Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator. Part number: 5704833 |
Code Information |
Oxylog 3000 plus, Part number: 5704833 with serial numbers: ASEK-0003, ASEK-0004, ASEK-0005 |
Recalling Firm/ Manufacturer |
Draeger Medical Systems, Inc. 3135 Quarry Rd Telford PA 18969-1042
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For Additional Information Contact | Customer Support 215-721-5400 |
Manufacturer Reason for Recall | The potentiometers (knobs) for setting the ventilation parameters may have contact interrupted and the device discontinues ventilation, gives an audible alarm and displays the error message Poti unplugged. |
FDA Determined Cause 2 | Process control |
Action | Drager sent an Urgent Medical Device Recall letter dated February 2014 to affected customers. The letter identified the affected device, problem and actions to be taken. The notification directed customers to perform manual ventilation in the event of a failure. Drager plans to repair the affected devices free of charge. If you have any questions regarding the Recall letter please call 1-800-543-5047 (press 1 at the prompt, then 2, then 32349). For questions regarding the operation and/or servicing of your Drger ventilator please contact DrgerService Technical Support at 1-800-543-5047 (press 4 at the prompt). |
Quantity in Commerce | 3 |
Distribution | USA Nationwide Distribution in the states of WI and NY. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = BTL
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