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Fresenius Medical Care Holdings, Inc. recalls Combiset Blood Line Hemodialysis use Catalog Number: 03-2622-3. Intended for use as the extracorporeal blood circui
Recalled November 20, 2013 · FDA recall Z-0186-2014 · Fresenius Medical Care Holdings
Hazard
Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual may disconnect and lead to blood loss · FDA Class II
Units
508,029 cases
Sold at
Worldwide Distribution-USA (nationwide) and the country of Canada.
Description
Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual may disconnect and lead to blood loss
Product
Combiset Blood Line Hemodialysis use Catalog Number: 03-2622-3. Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.
Manufacturer(s)
Fresenius Medical Care Holdings, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →