FDA-Device2013-07-10Class II
Delta Vaporizer An anesthetic vaporizer is a device used to vaporize liquid anesthetic and deliver a controlled amount of the vapor to the patient.
Penlon, Ltd.
Hazard
It has come to Penlon Ltd's attention of an instance where the installation and pre-use checks listed in the User Manual may not have been followed prior to the clinical use of the vaporizer. Penlon Ltd has updated the Installation and daily Pre-Use Check sections of the User Manual to ensure that the instructions are explicit and clear.
Sold states
Worldwide Distribution - USA including FL, KY, PA, ND, MN, IL, NJ, TX, TN, and VA. Internationally to Belgium, China, Czech Republic, France, Germany, Switzerland, Australia, Finland, Holland, Lithunia, Malta, Poland, and Slovakia.
Affected count
9208 (of which 576 were within the US)
Manufactured in
Abingdon Science Park, Barton Lane, Abingdon, N/A, United Kingdom
Products
Delta Vaporizer An anesthetic vaporizer is a device used to vaporize liquid anesthetic and deliver a controlled amount of the vapor to the patient.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1653-2013Don't want to check this manually?
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