Intersurgical Inc: Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg Model Number: 8003000

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

Details from the source

Reason for recall: 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 Distribution: OH, TN, TX Quantity: 340 pieces Lot/code info: UDI-DISingle unit: 5030267073511 UDI-DICase: 05030267046959 Lot code: 32204071

UPC codes

5030267073511, 05030267046959

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.