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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:184600

ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusion of: -crystalloid, colloid, or blood product, including packed red blood cells, as volume replacement for patients suffering from blood loss due to trauma or surgery -warmed fluid to rewarm patients after surgery or hypothermia -warmed fluid for irrigation in urology procedures

Official recall number

Z-1260-2021

Evidence summary

Product code
LGZ
Recall status
Terminated
Event initiated
February 18, 2021
Root cause
Component design/selection
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-1260-2021