FDA recall Z-0208-2018

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 for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2017-04-03

Report date

2017-12-13

Termination date

2019-06-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

E. Syracuse, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0208-2018