FDA Enforcement
Class II
Terminated
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.
Recall: Z-0208-2018
·
Reported December 13, 2017
Enforcement
- Recall Number
- Z-0208-2018
- Event ID
- 76945
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Intersurgical Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 13, 2017
- Initiation Date
- April 3, 2017
- Classification Date
- December 7, 2017
- Termination Date
- June 17, 2019
- Address
- 6757 Kinne St., N/A, E. Syracuse, NY, 13057, United States
Description
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.
Reason
A defect in the wire-reinforced tubing may result in a partial of total occlusion when the cuff is over-inflated.
Code Info
Product Lots: 31402822 to 31610791
Distribution
Worldwide Distribution - US Distribution to the states of : IL, KY, OH, NY & VA and to the countries of : Canada & Mexico
Quantity
144 cases / 20 units