• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of November 13, 2013

  • Print
  • Share
  • E-mail

Event Detail

Event ID 66464
Product Type Devices
Status Ongoing
Recalling Firm Sorin Group Deutschland GmbH
City Munchen
Country DE
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-09-24
Initial Firm Notification of
Consignee or Public
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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. 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 Class II Sorin Group is recalling certain models of S5 Perfusion Systems due to malfunction of cardioplegia control. 84 Z-0142-2014