Intersurgical Solus Flexible Laryngeal Mask Airways Recalled for Occlusion Risk
Intersurgical Inc is recalling Solus Flexible wire-reinforced laryngeal mask airways because a defect in the tubing may cause partial or total occlusion when the cuff is over-inflated.
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: The recall involves a medical device with a defect that may cause airway occlusion, a risk-of-harm condition where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Intersurgical Inc is recalling Solus Flexible wire-reinforced laryngeal mask airways in five sizes: small pediatric (size 2), large pediatric (size 2.5), small adult (size 3), medium adult (size 4), and large adult (size 5). The recall involves 144 cases, with 20 units per case, and covers product lots 31402822 through 31610791.
The recall is due to a defect in the wire-reinforced tubing that may result in partial or total occlusion when the cuff is over-inflated. This defect poses a risk to patients using the device for airway management.
The affected products were distributed worldwide, including in the United States (Illinois, Kentucky, Ohio, New York, and Virginia), Canada, and Mexico. Healthcare providers and consumers should stop using the affected devices and contact Intersurgical Inc for further instructions.
The recalled product
- Product
- Solus Flexible wire-reinforced laryngeal mask airways under the following sizes: 1) small pediatric size 2 catalog #8002001, 2) large pediatric size 2.5 catalog #8025001, 3) small adult size 3 catalog #8003001, 4) medium adult size 4 catalog #8004001 and 5) large adult size 5…
- Manufacturer
- Intersurgical Inc
- Hazard
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)
- Product Lots: 31402822 to 31610791
Distribution
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