FDA Device recall Z-0208-2018
Solus Flexible wire-reinforced laryngeal mask airways under the following sizes: 1) small pediatric size 2 catalog #8002001, 2) large pedia…
- FDA Device
- Class II
- terminated
- Published 2017-12-13
On 2017-12-13 the FDA classified a Class II recall of Solus Flexible wire-reinforced laryngeal mask airways under the following sizes: 1) small pediatric size 2 catalog #8002001, 2) large pedia… by Intersurgical, citing A defect in the wire-reinforced tubing may result in a partial of total occlusion when the cuff is over-inflated.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0208-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-04-03 |
| Published | 2017-12-13 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Intersurgical |
| Distribution | IL, KY, NY, OH, VA |
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.
Reason
A defect in the wire-reinforced tubing may result in a partial of total occlusion when the cuff is over-inflated.
Identifiers
| code_info | Product Lots: 31402822 to 31610791 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0208-2018%22
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