The Recall Desk
HighFDA (Devices)·Z-1812-2016·Announced 2016-06-01

Draeger D-Vapor Anesthesia Vaporizers Recalled for Anesthetic Agent Release

Draeger Medical is recalling D-Vapor and D-Vapor 3000 anesthesia vaporizers because they may release desflurane during filling, posing an eye irritation risk.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product where the hazard (serious eye irritation) is explicitly stated, but no injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria.

Plain-English summary

Draeger Medical, Inc. is recalling approximately 16,078 units of D-Vapor and D-Vapor 3000 anesthesia vaporizers (Catalog # M35500 and M36700) that were distributed in the United States, including Puerto Rico and Guam, between October 2004 and April 2016. The recall is due to an issue where operators noticed an unwanted release of the evaporating anesthetic agent, desflurane, at the end of the filling procedure.

The hazard associated with this recall is the potential for eye contact with the volatile anesthetic, which can result in serious irritation. The updated Material Safety Data Sheets (MSDS) for Desflurane recommend wearing safety glasses when handling these substances to prevent such exposure.

Healthcare facilities and operators who have these specific vaporizers should stop using them and contact Draeger Medical for instructions on how to proceed. If eye contact occurs, immediate eye flushing and consultation with a physician are recommended.

The recalled product

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
Affected units
16,078

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically: