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
| Model / number | Product as published |
|---|---|
8002001 | small pediatric size 2 |
8025001 | large pediatric size 2.5 |
8003001 | small adult size 3 |
8004001 | medium adult size 4 and |
8005001 | large 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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