Laryngeal mask airway recalled for incorrect size marking
Intersurgical Solus Standard size 3 laryngeal mask airways are marked with incorrect size 4 information, which may cause misuse or improper sizing of the airway device.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II device recall involving a medical airway device with mislabeled sizing information. No illnesses or injuries have been reported. The incorrect size markings create a risk of harm through potential misuse or improper device selection. This meets the rubric criterion: risk-of-harm products where injury has not yet been reported.
Plain-English summary
The Intersurgical Solus Standard laryngeal mask airway, size 3, has been recalled due to a printing error on the device. The device is marked with size 4 information rather than size 3, affecting the printed size identifier, patient weight range, and maximum inflation volume on the airway tube and pilot balloon.
Size 3 laryngeal mask airways are designed for small adults weighing 30-50 kg. The incorrect size 4 markings could lead to confusion or misuse of the device, potentially resulting in harm to patients.
The recall affects 340 units with lot code 32204071. Distribution includes Ohio, Tennessee, and Texas.
The recalled product
- Product
- Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg Model Number: 8003000
- Manufacturer
- Intersurgical Inc
- Category
- Medical Device — Airway Device
- Affected units
- 340
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DISingle unit: 5030267073511 UDI-DICase: 05030267046959 Lot code: 32204071
Distribution
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