Recall Z-1812-2016 ยท CAD Vaporizer, Anesthesia, Non-Heated
Draeger Medical, Inc.
Draeger D-Vapor/ D-Vapor 3000 Vaporizers with Baxter Desflurane Agent and Bottles. Catalog # M35500 (D-Vapor) and M36700 (D-Vapor 3000). Anesthesia Vaporizer
| Date | Apr 21, 2016 |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 16078 units distributed within the United States |
| Distribution | US nationwide distribution, including Puerto Rico and Guam. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042276 | D-VAPOR Draeger Medical, Inc., Sep 23, 2004 |