Intersurgical Solus Standard recall
Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg Model Number: 8003000
Why was Intersurgical Solus Standard recalled?
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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DISingle unit: 5030267073511 UDI-DICase: 05030267046959 Lot code: 32204071
- Product
- Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg Model Number: 8003000
- Recalling firm
- Intersurgical Inc
- Quantity
- 340 pieces
- Distribution
- OH, TN, TX
- Recall date
- October 26, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)