5 results
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23ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Medtronic Performer CPB-Universal R2100375. Catologue Number R5100052. The Performer CPB System is an electromechanical extracorporeal support device used during cardiopulmonary bypass procedures. Manufactured by: RanD S.r.l 41036 Mendolla (MO) Italy. Distributed exclusively by Medtronic, Inc.
FDA Recall
Terminated
·Medtronic Perfusion Systems·Product code DTQ·June 4, 2007
Hang&Go (kit for hyperthermic perfusion), Reference Code R9900120
FDA Enforcement
Class II
·Terminated·RanD S.r.l.·July 21, 2021
Ch24 round silicone catheter, Diameter: 8 mm, Perforated section: 230 mm, Total length: 600 mm, Reference Code R9900099. Thoracic/abdominal cavity drain catheter.
FDA Enforcement
Class II
·Terminated·RanD S.r.l.·July 21, 2021
Hang&Go (kit for hyperthermic perfusion), Reference Code R9900120
FDA Recall
Terminated
·RanD S.r.l. Strada Statale 62 Medolla Italy·Product code LGZ·April 30, 2021
Ch24 round silicone catheter, Diameter: 8 mm, Perforated section: 230 mm, Total length: 600 mm, Reference Code R9900099. Thoracic/abdominal cavity drain catheter.
FDA Recall
Terminated
·RanD S.r.l. Strada Statale 62 Medolla Italy·Product code LGZ·April 30, 2021