FDA Device recall Z-0142-2014
S5 Heart-lung machine, Stockert S5 System
- FDA Device
- Class II
- terminated
- Published 2013-11-13
On 2013-11-13 the FDA classified a Class II recall of S5 Heart-lung machine, Stockert S5 System by Sorin Group Deutschland, citing sorin Group is recalling certain models of S5 Perfusion Systems due to malfunction of cardioplegia control.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0142-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-09-24 |
| Published | 2013-11-13 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Sorin Group Deutschland |
| Distribution | AL, CA, CO, MA, MD, ND, NY, PR, SC, TN, TX, VA, WA, WI |
Product
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
Sorin Group is recalling certain models of S5 Perfusion Systems due to malfunction of cardioplegia control.
Identifiers
| code_info | Serial Numbers: 48E00235,48E00339,48E00342,48E01753,48E02767,48E02753,48E02745,48E02746,48E02748,48E02416,48E01033,480E…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 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0142-2014%22
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