medical MODERATE Updated 2017-12-13

Intersurgical Inc recalls Solus Flexible wire-reinforced laryngeal mask airways under

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Recalled 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.

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Hazard / Issue

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

Issued by

FDA

Affected States: IL, KY, OH, NY, VA
Lot/Code Info: Product Lots: 31402822 to 31610791

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
View official government recall