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Recall Observatory FDA recall evidence

Device 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

Z-1812-2016

April 21, 2016

Class II

Product summary

Firm
Draeger Medical, Inc.
Event
Event 73959
Status
Terminated
Classification
Class II
Quantity
16078 units distributed within the United States
Official record key
device-enforcement:Z-1812-2016

Official wording

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.

Code information: Catolog Number M35500 (D-Vapor) M36700 (D-Vapor 3000) Distributed October 2004  April 2016

Distribution pattern: US nationwide distribution, including Puerto Rico and Guam.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.