Z-0118-2015 Class II Terminated

The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professional Nebulizer System is suitable for use in adult and pediatric patients. The Aeroneb Solo Nebulizer System is an iteration of the Aeroneb Professional Nebulizer System which is single patient use. The FRIWO AC/DC adapter is a component of the Aerogen Nebulizer systems which is used to power the Pro and Pro X controllers.

Aerogen has received a small number of complaints in relation to the main power adapter manufactured by FRIWO GmbH and used in the Aeroneb Solo and Pro Nebuliser systems. The complaints received identified that the power adapter cover had broken and dislodged from the body of the adapter prior to use.

FRIWO AC/DC Adapter Model Number: GPP10; The FRIWO AC/DC Adapter is supplied with the following Aeroneb Nebulizer Pro family of systems: and their respective model numbers: 1) Model Number: AG-AP1040-AU; Lot Numbers: 8003140519057 , 8003140708015 , 8003140722089 ; 2) Model Number: AG-AP1040-EU; Lot Numbers: 800140731124 , 8000140520074 , 8000140520087 , 8000140520087 , 8000140530103 , 8000140619082 , 8000140620092 , 8000140624103 , 8000140624118 , 8000140701104 , 8000140702153 , 8000140721056 , 8000140726097 , 8000140728100 , 8000140728117 , 8000140728120 , 8000140625100, 8000140624100; 3) Model Number: AG-AP1040-UK; Lot Numbers: 8001140519067 , 8001140624115 , 8001140714044 , 8001140728065 , 8001140731125; 4) Model Number: AG-AP1040-US; Lot Numbers: 8002140520090 , 8002140521088 , 8002140522091 , 8002140522093 , 8002140523094 , 8002140523095 , 8002140526114 , 8002140527096 , 8002140603121 , 8002140603130 , 8002140613067 , 8002140613068 , 8002140616069 , 8002140616070 , 8002140626123 , 8002140627124 , 8002140627125 , 8002140627138 , 8002140711036 , 8002140714042 , 8002140721085 , 8002140721087 , 8002140722091 , 8002140722092 , 8002140722093; 5) Model Number: AG-AP1500-IN; Lot Numbers: 9948140702153; 6) Model Number: AG-AP1500-UK; Lot Numbers: 9953140801132; 7) Model Number: AG-AP1500-US; Lot Numbers: 9939140522091 , 9939140630138; 8) Model Number: AG-AP6000(DG)-FR; Lot Numbers: 9998140611025; 9) Model Number: AG-AP6000(DG)-GE; Lot Numbers: 9997140611024; 10) Model Number: AG-AP6000(DG)-IN; Lot Numbers: 9996140728059; 11) Model Number: AG-AP6000-AU; Lot Numbers: 9915140722056 , 9915140722089; 12) Model Number: AG-AP6000-CH; Lot Numbers: 9966140521021 , 9966140624102; 13) Model Number: AG-AP6000-FR; Lot Numbers: 9905140521074 , 9905140526108 , 9905140610023 , 9905140731072; 14) Model Number: AG-AP6000-GE; Lot Numbers: 9904140519141 , 9904140520089 , 9904140626100 , 9904140702149 , 9904140726097; 15) Model Number: AG-AP6000-IN; Lot Numbers: 9913140520026 , 9913140526077 , 9913140526102 , 9913140603083 , 9913140609009 , 9913140617074 , 9913140624117 , 9913140703160 , 9913140703160 , 9913140703164 , 9913140704022 , 9913140709028 , 9913140709029 , 9913140711152 , 9913140721008 , 9913140721057 , 9913140721078 , 9913140728104 , 9913140728111 , 9913140801129 , 9913140805137 , 9913140604097, 9913140603097 , 9913140609129, 9913140603129, 9913140724004, 9913140725004, 9913140729004, 9913140728004, 9913140723004; 16) Model Number: AG-AP6000-IT; Lot Numbers: 9906140515023 , 9906140710033; 17) Model Number: AG-AP6000-NO; Lot Numbers: 9916140519058; 18) Model Number: AG-AP6000-RU; Lot Numbers: 9968140704166, 9968140721077; 19) Model Number: AG-AP6000-SP; Lot Numbers: 9907140519028 , 9907140730097; 20) Model Number: AG-AP6000-SW; Lot Numbers: 9927140607011; 21) Model Number: AG-AP6000-UK; Lot Numbers: 9903140520025 , 9903140526111 , 9903140722056 , 9903140728098; 22) Model Number: AG-AP6000-US; Lot Numbers: 9902140616065 , 9902140616067 , 9902140617070