FDAClass IIJune 1, 2016

Draeger D-Vapor/ D-Vapor 3000 Vaporizers with Baxter recall

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

Why was Draeger D-Vapor/ D-Vapor 3000 Vaporizers with Baxter 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Draeger D-Vapor/ D-Vapor 3000 Vaporizers with Baxter Desflurane Agent and Bottles. Catalog # M35500 (D-Vapor) and M36700 (D-Vapor 3000). Anesthesia…
Recalling firm
Draeger Medical, Inc.
Quantity
16078 units distributed within the United States
Distribution
US nationwide distribution, including Puerto Rico and Guam.
Recall date
June 1, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls