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U.S. Department of Health and Human Services

Class 2 Device Recall Desflurane Vaporizer

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  Class 2 Device Recall Desflurane Vaporizer see related information
Date Initiated by Firm April 21, 2016
Create Date May 25, 2016
Recall Status1 Terminated 3 on December 07, 2016
Recall Number Z-1812-2016
Recall Event ID 73959
510(K)Number K042276  
Product Classification Vaporizer, anesthesia, non-heated - Product Code CAD
Product Draeger D-Vapor/ D-Vapor 3000 Vaporizers with Baxter Desflurane Agent and Bottles. Catalog # M35500 (D-Vapor) and M36700 (D-Vapor 3000). Anesthesia Vaporizer
Code Information Catolog Number M35500 (D-Vapor) M36700 (D-Vapor 3000) Distributed October 2004  April 2016
Recalling Firm/
Manufacturer		 Draeger Medical, Inc.
3135 Quarry Rd
Telford PA 18969-1042
For Additional Information Contact Michael A. Kelhart
215-660-2349
Manufacturer Reason
for Recall		 Operators noticed unwanted release of evaporating anesthetic agent at the end of the filling procedure. Eye contact with volatile anesthetics can result in serious irritation. Immediate eye flushing and consultation of a physician is recommended. Updated Material Safety Data Sheets (MSDS) for Desflurane recommend wearing safety glasses when handling these substances.
FDA Determined
Cause 2		 Process change control
Action Drager mailed a "Medical Device Safety Alert" dated April 21, 2016, to customers informing them of the problem and provided instructions for the "correct filling procedure" and recommendations on how to prevent evaporation and spraying of Desflurane after bottle release to resolve the "High Friction of gas bottle valve" problem.
Quantity in Commerce 16078 units distributed within the United States
Distribution US nationwide distribution, including Puerto Rico and Guam.
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 = CAD and Original Applicant = DRAEGER MEDICAL, INC.
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