FDA Device recall Z-2346-2024
RTL190904: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - 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 RTL190904: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - 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-2346-2024 |
| 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
RTL190904: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - 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: RTL190904 (Rental Units); UDI/DI: 00840861100965; Serial Numbers: 5K0S193320, 5K0S194164. |
|---|
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-2346-2024%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.