Recall Z-0096-2023— Intersurgical Inc
Class II · Terminated
Class II FDA medical device recall by Intersurgical Inc, initiated 2022-08-29, terminated 2023-10-19. FDA's recall record names no specific 510(k) clearance for this event. Product: Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg Model Number: 8003000. Reason: 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.
- Recalling firm
- Intersurgical Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2022-08-29
- Terminated
- 2023-10-19
- Firm location
- East Syracuse, NY, United States
Product description
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.