[Recalled] Sorin Stockert Heater-Cooler 3T, 120 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours. — Potential colonization of organisms, including Mycobacteria, in Sorin Heater Co… | FDA 2015-06-15
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| Product | Sorin Stockert Heater-Cooler 3T, 120 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours. |
|---|---|
| Brand / manufacturer | Sorin Group USA, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2080-2015 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 15 June 2015 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if proper disinfection and maintenance is not performed per Instructions for Use.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Sorin Group USA, Inc.
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.