Corrective action reporting for FMI 39002 : AMSORB® PLUS PREFILLED G-CAN® 1.0L—CO2Absorbers with high flow resistance

 

Affected Medical Device : AMSORB® PLUS PREFILLED G-CAN® 1.0L

 

MDA Reference Number : MDA/FCA/2021-P131

 

MDA Registration Number : GB5461720-40995

 

Decription : Armstrong Medical is aware of reports indicating that a small number of devices are associated with high and unexpected resistance to gas flow during clinical use.

 

Local Establishment Contact Detail :

Benedict Lee
ASEAN Regulatory Affairs Specialist
GE Healthcare Sdn Bhd
Level 6, 1 Sentral, Jln Travers, KL Sentral, 50470 KL
03 22739788

Email : benedict.lee@ge.com

 

 A copy of FSN.