Z-0096-2023 Class II Terminated
FDA device recall Z-0096-2023 was initiated by Intersurgical Inc on August 29, 2022 and is designated Class II. 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 in… The recall status is terminated (terminated October 19, 2023). Affected quantity: 340 pieces.
Recall Details
- Product Type
- Devices
- Report Date
- October 26, 2022
- Initiation Date
- August 29, 2022
- Termination Date
- October 19, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 340 pieces
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
Distribution Pattern
OH, TN, TX
Code Information
UDI-DISingle unit: 5030267073511 UDI-DICase: 05030267046959 Lot code: 32204071