FDAFDA · Food and drugs·Recall number Z-0142-2014
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.
Published November 13, 2013 · Recall initiated: September 24, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Sorin Group is recalling certain models of S5 Perfusion Systems due to malfunction of cardioplegia control.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Sorin Group Deutschland GmbH
- Distributor
- 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.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Germany
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.