Intersurgical Inc recalls Solus Flexible wire-reinforced laryngeal mask airways under the following sizes: 1) small pediatric size 2 catalog #800…

Recall date

April 3, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0208-2018

FDA classification

Class II

Brand / firm

Intersurgical Inc

Sold / distributed

Worldwide Distribution - US Distribution to the states of : IL, KY, OH, NY & VA and to the countries of : Canada & Mexico

Why it was recalled

A defect in the wire-reinforced tubing may result in a partial of total occlusion when the cuff is over-inflated.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.