FDAClass IIDecember 13, 2017

Solus Flexible wire-reinforced laryngeal mask airways recall

Solus Flexible wire-reinforced laryngeal mask airways under the following sizes: 1) small pediatric size 2 catalog #8002001, 2) large pediatric size…

Why was Solus Flexible wire-reinforced laryngeal mask airways recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Product Lots: 31402822 to 31610791

Product
Solus Flexible wire-reinforced laryngeal mask airways under the following sizes: 1) small pediatric size 2 catalog #8002001, 2) large pediatric size…
Recalling firm
Intersurgical Inc
Quantity
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
Recall date
December 13, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
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