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U.S. Department of Health and Human Services

Enforcement Report - Week of November 13, 2013

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Product Detail

Product Description S5 Heart-lung machine, Stockert S5 System. Catalogue No: 48-30/40/50-00. The Stockert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six(6) hours or less.
Recall Number Z-0142-2014
Classification Class II
Code Info Serial Numbers: 48E00235,48E00339,48E00342,48E01753,48E02767,48E02753,48E02745,48E02746,48E02748,48E02416,48E01033,480E1038,48E01040,48E01041,48E01043,48E01044,48E01051,48E02631,48E01183,48E02758,48E02764,48E01832,48E01834,48E02278,48E02722,48E02732,48E02326,48E02797,48E02793,48E02791,48E02781,48E02785,48E02786,48E02783,48E02772,48E02802,48E02778,48E02784,48E02788,48E02789,48E02779,48E02792,48E02790,48E02771,48E02773,48E02776,48E02799,48E02801
Product Distributed Qty 84
Reason For Recall Sorin Group is recalling certain models of S5 Perfusion Systems due to malfunction of cardioplegia control.

Event Detail

Event Id 66464
Product Type Devices
Status Ongoing
Recalling Firm Sorin Group Deutschland GmbH
City Munchen
State
Country DE
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-09-24
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - USA including WA, NY, VA, TN, SC, TX, CA, CO, MA, WI, MD, AL, ND, and Puerto Rico and Internationally to Italy, Finland, Germany, Sweden, and Great Britain.
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