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U.S. Department of Health and Human Services

Class 2 Device Recall Oxylog 3000

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 Class 2 Recall
Oxylog 3000
see related information
Date Posted October 07, 2010
Recall Status1 Terminated on November 18, 2010
Recall Number Z-0018-2011
Recall Event ID 56600
Premarket Notification
510(K) Number
K062267 
Product Classification Ventilator, Continuous, Facility Use - 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, Pennsylvania 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
PRODUCTION CONTROLS: 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 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 = DRAGER MEDICAL B.V.
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