Recall Z-0208-2018 ยท BYG Mask, Oxygen
Intersurgical Inc
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.
| Date | Apr 3, 2017 |
| Status | Terminated |
| Reason | A defect in the wire-reinforced tubing may result in a partial of total occlusion when the cuff is over-inflated. |
| Root cause | Nonconforming Material/Component |
| Action | Intersurgical sent an Urgent Medical Device Recall Notice dated April 3rd, 2017, along with response forms to Customers. Customers were advised to immediately discontinue use and quarantine affected products. If affected products were further distributed, customers are advised to notify those individuals and advise them of the recall situation and have them return their outstanding stock to you. Customers with questions can call the IS Customer Service line at 800-828-9633 for a Return Authorization Number. Once customers receive the Return Authorization Number, please enter it in the space |
| Quantity | 144 cases / 20 units |
| Distribution | Worldwide Distribution - US Distribution to the states of : IL, KY, OH, NY & VA and to the countries of : Canada & Mexico |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.