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Intersurgical Inc recalls Solus Flexible wire-reinforced laryngeal mask airways under the following sizes: 1) small pediatric size 2 catalog #800
Recalled December 13, 2017 · FDA recall Z-0208-2018 · Intersurgical
Hazard
A defect in the wire-reinforced tubing may result in a partial of total occlusion when the cuff is over-inflated. · FDA Class II
Units
144 cases / 20 units
Sold at
Worldwide Distribution - US Distribution to the states of : IL, KY, OH, NY & VA and to the countries of : Canada & Mexico
Description
A defect in the wire-reinforced tubing may result in a partial of total occlusion when the cuff is over-inflated.
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.
Manufacturer(s)
Intersurgical Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →