Reported Dec 13, 2017 · Terminated

Solus Flexible wire-reinforced laryngeal mask airways under the following sizes

Intersurgical Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Intersurgical Inc · 6757 Kinne St. · E. Syracuse, NY · 13057

Is this the product you have?

Solus Flexible wire-reinforced laryngeal mask airways under the following sizes

5 of 5 products

Products covered by this recall
Model / numberProduct as published
8002001small pediatric size 2
8025001large pediatric size 2.5
8003001small adult size 3
8004001medium adult size 4 and
8005001large adult size 5 Patent airway management.
Lot codes and dates
  • Product Lots31402822 to 31610791
Amount recalled
144 cases / 20 units

Where it was sold

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 17, 2019 · Data as of Sep 19, 5:28 PM UTC

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