FDA-Device2025-12-03Class IIPROCESSING DEFECT
Sevoflurane (SEVO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: 1. Sev E_Vap. (Safety Filling adapter), Part Number: 115-066756-00. 2. Exchange Sev E_Vap. (Safety Filling adapter), Part Number: E115-066756-00. Product Description: The Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The A9 Anesthesia System utilizes V90 electronic v
Hazard
Potential for anesthesia leakage.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide - US Nationwide distribution in the states of California, Florida, Georgia, Kentucky, Maryland, Mississippi, Missouri, New Jersey, Puerto Rico, Texas, Washington, West Virginia and the country of Canada.
Affected count
148 units
Manufactured in
800 Macarthur Blvd, N/A, Mahwah, NJ, United States
Products
Sevoflurane (SEVO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: 1. Sev E_Vap. (Safety Filling adapter), Part Number: 115-066756-00. 2. Exchange Sev E_Vap. (Safety Filling adapter), Part Number: E115-066756-00. Product Description: The Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The A9 Anesthesia System utilizes V90 electronic vaporizers for anesthetic agent delivery.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0720-2026Want us to check the next one for you?
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