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Manufacturers
Gambro Pty Ltd
Manufacturer Parent Company (2017)
Baxter International
Source
DHTGA
6 Events
Recall of AK 200 S and AK 200 ULTRA S nocturnal home hemodialysis machines
Recall of Artis Dialysis System equipped with SW 8.15.06 and 8.33.02
Recall of Revaclear and Revaclear Max Dialysers (Hollow-fibre haemodialysis dialyser)
Recall of Ultrafilter U9000 (Used on Gambro Haemodialysis Delivery Systems.)
Recall of PRISMA, PRISMAFLEX, X-MARS and ADSORBA sets
Recall of Gambro Conventional Bloodlines; BL200 BD Pre Post, BL208 BD & BL223PB (dialysis/haemodialysis tubing set)BL200 BD Pre Post
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6 devices in the database
AK 200 S and AK 200 ULTRA S nocturnal home hemodialysis machines
Model / Serial
AK 200 S and AK 200 ULTRA S nocturnal home hemodialysis machinesARTG Number: 112135
Artis Dialysis System equipped with SW 8.15.06 and 8.33.02
Model / Serial
Artis Dialysis System equipped with SW 8.15.06 and 8.33.02ARTG Number: 141189
Revaclear and Revaclear Max Dialysers (Hollow-fibre haemodialysis dialyser)
Model / Serial
Revaclear and Revaclear Max Dialysers (Hollow-fibre haemodialysis dialyser)Product Codes: 110633 & 110634Multiple lot numbers are affectedARTG Number: 194549
Ultrafilter U9000 (Used on Gambro Haemodialysis Delivery Systems.)
Model / Serial
Ultrafilter U9000 (Used on Gambro Haemodialysis Delivery Systems.)ARTG Number: 131741
PRISMA, PRISMAFLEX, X-MARS and ADSORBA sets
Model / Serial
PRISMA, PRISMAFLEX, X-MARS and ADSORBA sets
One more
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