FDAFDA · Food and drugs·Recall number Z-0208-2018
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.
Published December 13, 2017 · Recall initiated: April 3, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
A defect in the wire-reinforced tubing may result in a partial of total occlusion when the cuff is over-inflated.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Intersurgical Inc
- Distributor
- Worldwide Distribution - US Distribution to the states of : IL, KY, OH, NY & VA and to the countries of : Canada & Mexico
- Lot
- Product Lots: 31402822 to 31610791
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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