Recall Z-2076-2015— Sorin Group USA, Inc.
Class II · Terminated
Class II FDA medical device recall by Sorin Group USA, Inc., initiated 2015-06-15, terminated 2018-07-25. It names one FDA 510(k) clearance: K052601. 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..
- Recalling firm
- Sorin Group USA, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-06-15
- Terminated
- 2018-07-25
- Firm location
- Arvada, CO, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Sorin Stockert Heater-Cooler 3T, 230 V Temperature control for extracorporeal perfusion of durations up to 6 hours.
Reason for recall
Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if proper disinfection and maintenance is not performed per Instructions for Use.
Data sourced from openFDA. This site is unofficial and independent of the FDA.