FDA recall Z-0096-2023

Product

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

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

Key facts

Status

Terminated

Initiation date

2022-08-29

Report date

2022-10-26

Termination date

2023-10-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

East Syracuse, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0096-2023