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U.S. Department of Health and Human Services

Class 2 Device Recall Oxylog 3000

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  Class 2 Device Recall Oxylog 3000 see related information
Date Initiated by Firm August 19, 2010
Date Posted October 07, 2010
Recall Status1 Terminated 3 on November 18, 2010
Recall Number Z-0018-2011
Recall Event ID 56600
510(K)Number K062267  
Product Classification Facility Use Continuous Ventilator - Product Code CBK
Product Oxylog 3000, Emergency and Transport Ventilator; Catalog #2M86300; Drager Medical Inc., 3135 Quarry Road, Telford, PA 18969.
Code Information only units manufactured before 9/08
Recalling Firm/
Manufacturer		 Draeger Medical Systems, Inc.
3135 Quarry Rd
Telford PA 18969-1042
For Additional Information Contact Mike Kelhart
215-660-2349
Manufacturer Reason
for Recall		 Patients received insufficient ventilation. The Oxylog 3000 Instructions are inadequate relating to dead space volume.
FDA Determined
Cause 2		 Error in labeling
Action The firm sent Important Safety Notice Letter, dated August 2010, and Instructions for Use supplement to consignees. The letter explained the issue with the affected product. The letter asks customers to attach the Instructions for Use amendment sheet supplied with the letter to their corresponding Instructions for Use. The firm also states that a they will provide a dedicated pediatric breathing circuit for the Oxylog 3000. Questions regarding the letter should be directed to Michael Kelhart at 1-800-543-5047. Questions regarding the use of the device should be directed to DragerService Technical Support at 1-800-543-5047 or your local Drager Sales Representative.
Quantity in Commerce 78 potentially afftected units
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = CBK and Original Applicant = DRAGER MEDICAL B.V.
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