FDA Device recall Z-2341-2024
190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
- FDA Device
- Class II
- ongoing
- Published 2024-07-17
On 2024-07-17 the FDA classified a Class II recall of 190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A by Fresenius Medical Care Holdings, citing an increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2341-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-06-03 |
| Published | 2024-07-17 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Fresenius Medical Care Holdings |
| Distribution | US |
Product
190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Reason
An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
Identifiers
| code_info | Model Number: 190828; UDI/DI: 00840861100941; Serial Numbers: 2K0S179489, 3K0S184885, 3K0S185744, 1K0S172050, 1K0S17220…Model Number: 190828; UDI/DI: 00840861100941; Serial Numbers: 2K0S179489, 3K0S184885, 3K0S185744, 1K0S172050, 1K0S172202, 1K0S171823, 1K0S172056, 3K0S185989, 3K0S186038, 4K0S190849, 4K0S191132, 1K0S171846, 4K0S192532, 4K0S192534, 4K0S192232, 4K0S191583, 2K0S180629, 3K0S185738, 4K0S190517, 1K0S171488, 1K0S172266, 4K0S192736, 3K0S185730, 3K0S185732, 3K0S185734, 3K0S185740, 3K0S186955, 3K0S187000, 4K0S190509, 4K0S190514, 4K0S190515, 4K0S190519, 4K0S190525, 4K0S190537, 4K0S191511, 4K0S191571, 4K0S191578, 4K0S192514, 4K0S192520, 4K0S192522, 4K0S192523, 4K0S192528, 4K0S192538, 4K0S192235, 4K0S192231, 4K0S192236, 4K0S192237, 2K0S180521, 2K0S180522, 2K0S180527, 3K0S186036, 3K0S182626, 3K0S182627, 3K0S182637, 3K0S182646, 3K0S184910, 3K0S185719, 3K0S185721, 3K0S185739, 3K0S185742, 3K0S186938, 3K0S186951, 3K0S186953, 3K0S186960, 3K0S186995, 3K0S186997, 4K0S190280, 4K0S191586, 4K0S191229, 4K0S191230, 4K0S191232, 4K0S191569, 4K0S191579, 4K0S191580, 4K0S192727, 4K0S192731, 2K0S179494, 2K0S179487, 3K |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2341-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.