CLASS II Device recall · Reported 28 Aug 2013 · FDA Enforcement Report

Edwards Lifesciences Suction Wand recalled by Sorin Group USA

Sorin Group USA is recalling Edwards Lifesciences Suction Wand, distributed nationwide in the US. The recall was initiated on 8 Jul 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel S099B

Quantity recalled18,927 packs

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1985-2013
FDA event ID: 65869
Recalling firm: Sorin Group USA, Arvada, CO
Classification: Class II
Status: Terminated
Recall initiated: 8 Jul 2013
FDA classified: 20 Aug 2013
Reported: 28 Aug 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Particulate Matter
Device type: Other Medical Devices

Timeline

8 Jul 2013	Recall initiated by company
20 Aug 2013	Classified by FDA	+43 days
28 Aug 2013	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

Nationwide Distribution

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Model S099B

Where was it sold?

Nationwide Distribution

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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