Draeger D-Vapor/ D-Vapor 3000 Vaporizers with Baxter Desflurane Agent and Bottles. Catalog # M35500 (D-Vapor) and M36700 (D-Vapor 3000). Anesthesia Vaporizer
This recall has been terminated (originally issued April 21, 2016).
- Company
- Draeger Medical, Inc.
- Recall Initiated
- April 21, 2016
- Terminated
- December 7, 2016
- Recall Number
- Z-1812-2016
- Quantity
- 16078 units distributed within the United States
- Firm Location
- Telford, PA
- Official Source
- View on FDA website ↗
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.
Distribution
US nationwide distribution, including Puerto Rico and Guam.
Lot / Code Info
Catolog Number M35500 (D-Vapor) M36700 (D-Vapor 3000) Distributed October 2004 April 2016
Root Cause
Process change control
Action Taken
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.