The US Food and Drug Administration (FDA) has announced an urgent recall of certain Draeger Vapor 2000 and Vapor 3000 anesthetic vaporizers due to potential safety risks. This recall affects healthcare professionals and organizations that use these devices in clinical settings.
What Changed?
Draeger has issued a letter to affected customers recommending the removal of certain Vapor 2000 and Vapor 3000 vaporizers from use and sale. The reason for this recall is the presence of impurities in a certain component of the vaporizers, which may cause serious injury or death if ingested or inhaled by patients.
Affected Devices
The affected devices include certain serial numbers of the Vapor 2000 and Vapor 3000 vaporizers. A full list of affected serial numbers is available. Healthcare professionals and organizations should check their devices against this list and take immediate action if their device is affected.
Reason for Recall
The recall is due to the presence of impurities, specifically metal residues from ineffective cleaning after soldering, in a certain production lot of the vaporizers. These impurities may react with volatile fluorinated gases and cause lung tissue damage, tracheobronchial irritation, and pulmonary edema in patients.
Actions to Take
Healthcare professionals and organizations should not use the affected vaporizers and should take the following actions: contact Draeger to arrange for replacement, clean the breathing system of the anesthesia device according to the instructions for use, and ensure that all users of the affected products are aware of this urgent medical device recall notice.
Conclusion
In conclusion, the FDA recall of certain Draeger Vapor 2000 and Vapor 3000 anesthetic vaporizers is a serious safety issue that requires immediate attention from healthcare professionals and organizations. By taking the recommended actions, healthcare providers can minimize the risk of patient harm and ensure a safe clinical environment.
Disclaimer
This information is not intended to be legal advice. Healthcare professionals and organizations should consult the FDA website and relevant regulations for the most up-to-date information on this recall.
For full information about the FDA announcement, see the link below.
https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/anesthetic-vaporizer-recall-draeger-removes-vapor-2000-and-vapor-3000-vaporizers