Z-1812-2016Class II

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

Name: Z-1812-2016 Draeger D-Vapor/ D-Vapor 3000 Vaporizers with Baxter Desflurane Agent and Bottles. Catalog # M35500 (D-Vapor)...
Creator: Draeger Medical, Inc.
Published: 2016-04-21
License: https://open.fda.gov/license/

Draeger, Inc. / initiated 2016-04-21 / Terminated

FDA source

Draeger Medical, Inc. began a recall of Draeger D-Vapor/ D-Vapor 3000 Vaporizers with Baxter Desflurane Agent and Bottles. Catalog # M35500 (D-Vapor) and M36700 (D-Vapor 3000). Anesthesia Vaporizer on 2016-04-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1812-2016
Classification: Class II
Status: Terminated
Initiated: 2016-04-21
Posted: 2016-05-25
Terminated: 2016-12-07
Recalling firm: Draeger, Inc.
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
Product code: CAD Vaporizer, Anesthesia, Non-Heated
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.
FDA root cause: Process change control
Action: Drager mailed a "Medical Device Safety Alert" dated April 21, 2016, to customers informing them of the problem and provided instructions for the "correct filling procedure" and recommendations on how to prevent evaporation and spraying of Desflurane after bottle release to resolve the "High Friction of gas bottle valve" problem.
Quantity in commerce: 16078 units distributed within the United States
Distribution: US nationwide distribution, including Puerto Rico and Guam.
Product codes and lots: Catolog Number M35500 (D-Vapor) M36700 (D-Vapor 3000) Distributed October 2004 April 2016

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1812-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1812-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-01	2016-05-25

Product code CAD

K042276Class IID-VaporDraeger Medical, Inc. / cleared 2004-09-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)