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.
Reported: December 13, 2017 Initiated: April 3, 2017 #Z-0208-2018
Product Description
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.
Details
- Recalling Firm
- Intersurgical Inc
- Units Affected
- 144 cases / 20 units
- Distribution
- Worldwide Distribution - US Distribution to the states of : IL, KY, OH, NY & VA and to the countries of : Canada & Mexico
- Location
- E. Syracuse, NY
Frequently Asked Questions
What product 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.. Recalled by Intersurgical Inc. Units affected: 144 cases / 20 units.
Why was this product recalled? ▼
A defect in the wire-reinforced tubing may result in a partial of total occlusion when the cuff is over-inflated.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 13, 2017. Severity: Moderate. Recall number: Z-0208-2018.
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