FDA-Device2013-11-20Class II
2008K@ Home Blood lines Combiset True Flow Series for Hemodialysis use Catalog Number: 03-2962-3. Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.
Fresenius Medical Care Holdings, Inc.
Hazard
Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual may disconnect and lead to blood loss
Sold states
Worldwide Distribution-USA (nationwide) and the country of Canada.
Affected count
8,528 cases
Manufactured in
920 Winter St, Waltham, MA, United States
Products
2008K@ Home Blood lines Combiset True Flow Series for Hemodialysis use Catalog Number: 03-2962-3. Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0184-2014Don't want to check this manually?
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