Device 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 catalog #8005001 Patent airway management.
Z-0208-2018
Product summary
- Event
- Event 76945
- Status
- Terminated
- Classification
- Class II
- Quantity
- 144 cases / 20 units
- Official record key
device-enforcement:Z-0208-2018
Official wording
Reason: A defect in the wire-reinforced tubing may result in a partial of total occlusion when the cuff is over-inflated.
Code information: Product Lots: 31402822 to 31610791
Distribution pattern: Worldwide Distribution - US Distribution to the states of : IL, KY, OH, NY & VA and to the countries of : Canada & Mexico
Derived failure modes
-
Unknown
A defect in the wire-reinforced tubing may result in a partial of total occlusion when the cuff is over-inflated.