FDAClass IIAugust 28, 2013

Edwards Lifesciences Suction Wand recall

Edwards Lifesciences Suction Wand Model S099B, packaged in Sorin Group Heart/Lung Perfusion Packs.

Why was Edwards Lifesciences Suction Wand recalled?

Sorin Group is recalling certain lots of Edwards Lifesciences Suction Wand Model S099B due to presence of plastic particles inside the pouch.

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?

Model S099B

Product
Edwards Lifesciences Suction Wand Model S099B, packaged in Sorin Group Heart/Lung Perfusion Packs.
Recalling firm
Sorin Group USA, Inc.
Quantity
18,927 packs
Distribution
Nationwide Distribution
Recall date
August 28, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
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