Sorin Group Deutschland GmbH: Medical Device Recall in 2013 - (Recall #: Z-0142-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: September 24, 2013

Date Posted: November 13, 2013

Recall Number: Z-0142-2014

Event ID: 66464

Reason for Recall:

Sorin Group is recalling certain models of S5 Perfusion Systems due to malfunction of cardioplegia control.

Status: Terminated

Product Quantity: 84

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

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.

Voluntary or Mandated:

Voluntary: Firm initiated