Medical device recalls Moderate risk

Draeger Medical, Inc. recalls Draeger D-Vapor/ D-Vapor 3000 Vaporizers with Baxter Desflurane Agent and Bottles. Catalog # M35500 (D-Vapor) and M3670…

Recall date
April 21, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1812-2016
FDA classification
Class II
Brand / firm
Draeger Medical, Inc.
Sold / distributed
US nationwide distribution, including Puerto Rico and Guam.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Draeger D-Vapor/ D-Vapor 3000 Vaporizers with Baxter Desflurane Agent and Bottles. Catalog # M35500 (D-Vapor) and M36700 (D-Vapor 3000). Anesthesia Vaporizer

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