This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.

Affected Product

The FDA is aware that Draeger has issued a letter to affected customers recommending certain Vapor 2000 and Vapor 3000 Vaporizers be removed from where they are used or sold. Affected devices:

Full list of affected serial numbers

What to Do

Do not use affected Vaporizers.

On November 24, Draeger sent all affected customers a letter recommending the following actions:

• Do not use the affected Vaporizers.
• You will be contacted by your local Draeger representative to arrange for the replacement of your Vaporizer.
• If you have already placed the vaporizer into clinical use, we ask you to clean the breathing system of the anesthesia device(s) according to the Instructions for use. The use of inspiratory filters is recommended.
• Please ensure that all users of the affected products and other persons within your organization are made aware of this Urgent Medical Device Recall Notice. If you have provided the products to third parties, please forward a copy of this information.
• Please retain Draeger’s Urgent Medical Device Recall notice at least until your Vapor 2000/3000 has been replaced.

Reason for Recall

Draeger stated that a certain component of the Vapor 2000 and Vapor 3000 was not delivered by the relevant supplier in accordance with the specification. Impurities resulting from the production process at the supplier site were found inside a certain production lot of the Vaporizers.

Impurities (i.e., metal residues from ineffective cleaning after soldering) and their chemical reaction with volatile fluorinated gases may be ingested or inhaled by the patient.  Risks include lung tissue damage, tracheobronchial (windpipe and lung airways) irritation, and pulmonary edema.

As of December 1, Draeger has not reported any serious injuries or deaths associated with this issue.

Device Use

Vapor 2000 and 3000 are unheated, calibrated anesthetic vaporizers for the enrichment of dry, fresh medical gas in anesthesia workstations with precisely controlled concentrations of vapor from liquid anesthetic agents.

Contact Information

Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Draeger at 1-800-437-2437 (press 2 at the prompt, then 2, then 2 again).

Additional FDA Resources

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.