FDA Device recall Z-2076-2015
Sorin Stockert Heater-Cooler 3T, 230 V Temperature control for extracorporeal perfusion of durations up to 6 hours
- FDA Device
- Class II
- terminated
- Published 2015-07-22
On 2015-07-22 the FDA classified a Class II recall of Sorin Stockert Heater-Cooler 3T, 230 V Temperature control for extracorporeal perfusion of durations up to 6 hours by Sorin Group Usa, citing potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if proper disinfection and maintenance is not performed per Instructions for Use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2076-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-06-15 |
| Published | 2015-07-22 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Sorin Group Usa |
| Distribution | US |
Product
Sorin Stockert Heater-Cooler 3T, 230 V Temperature control for extracorporeal perfusion of durations up to 6 hours.
Reason
Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if proper disinfection and maintenance is not performed per Instructions for Use.
Identifiers
| code_info | Product code 16-02-80 Serial number 16S10027-16S15641 |
|---|
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-2076-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.