PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: June 1, 2016 Initiated: April 21, 2016 #Z-1812-2016

Product Description

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

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.

Details

Recalling Firm
Draeger Medical, Inc.
Units Affected
16078 units distributed within the United States
Distribution
US nationwide distribution, including Puerto Rico and Guam.
Location
Telford, PA

Frequently Asked Questions

What product 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. Recalled by Draeger Medical, Inc.. Units affected: 16078 units distributed within the United States.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 1, 2016. Severity: Moderate. Recall number: Z-1812-2016.