Recall Z-0208-2018— Intersurgical Inc
Class II · Terminated
Class II FDA medical device recall by Intersurgical Inc, initiated 2017-04-03, terminated 2019-06-17. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Intersurgical Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-04-03
- Terminated
- 2019-06-17
- Firm location
- E. Syracuse, NY, United States
Product 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 for recall
A defect in the wire-reinforced tubing may result in a partial of total occlusion when the cuff is over-inflated.
Data sourced from openFDA. This site is unofficial and independent of the FDA.