FDA-Device2022-10-26Class II
Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg Model Number: 8003000
Intersurgical Inc
Hazard
Printing error on the device, size 3 Solus Standard laryngeal mask airway has been incorrectly marked with size 4 information (includes the number 4 as a size identifier, patient weight and maximum inflation volume on the airway tube and the marking #4 on the inflation line pilot balloon) may pose health risk to the patient
Sold states
OH, TN, TX
Affected count
340 pieces
Manufactured in
6757 Kinne St, N/A, East Syracuse, NY, United States
Products
Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg Model Number: 8003000
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0096-2023Don't want to check this manually?
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