Z-0142-2014 Class II Terminated
FDA device recall Z-0142-2014 was initiated by Sorin Group Deutschland GmbH on September 24, 2013 and is designated Class II. Reason for recall: Sorin Group is recalling certain models of S5 Perfusion Systems due to malfunction of cardioplegia control. The recall status is terminated (terminated July 10, 2014). Affected quantity: 84.
Recall Details
- Product Type
- Devices
- Report Date
- November 13, 2013
- Initiation Date
- September 24, 2013
- Termination Date
- July 10, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 84
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.
Reason for Recall
Sorin Group is recalling certain models of S5 Perfusion Systems due to malfunction of cardioplegia control.
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.
Code Information
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