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U.S. Department of Health and Human Services

Enforcement Report - Week of August 28, 2013

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Product Detail

Product Description Edwards Lifesciences Suction Wand Model S099B, packaged in Sorin Group Heart/Lung Perfusion Packs.
Recall Number Z-1985-2013
Classification Class II
Code Info Model S099B
Product Distributed Qty 18,927 packs
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.

Event Detail

Event Id 65869
Product Type Devices
Status Ongoing
Recalling Firm Sorin Group USA, Inc.
City Arvada
State CO
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-07-08
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution