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Intersurgical Inc recalls Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg Model Number: 8003000
Recalled October 26, 2022 · FDA recall Z-0096-2023 · Intersurgical
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 · FDA Class II
Units
340 pieces
Sold at
OH, TN, TX
Description
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
Product
Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg Model Number: 8003000
Manufacturer(s)
Intersurgical Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →