FDA Device recall Z-0030-2024
2008T Hemodialysis System w/Bibag
- FDA Device
- Class I
- ongoing
- Published 2023-10-18
On 2023-10-18 the FDA classified a Class I recall of 2008T Hemodialysis System w/Bibag by Fresenius Medical Care Holdings, citing potential PCBA leaching from tubing of hemodialysis machines.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0030-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-09-06 |
| Published | 2023-10-18 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Fresenius Medical Care Holdings |
| Distribution | US |
Product
2008T Hemodialysis System w/Bibag
Reason
Potential PCBA leaching from tubing of hemodialysis machines.
Identifiers
| code_info | Model No: 190766; UDI-DI: 00840861100910; Serial No. 1T0S261032, 1T0S261004, 1T0S261029, 1T0S260995, 1T0S260937, 1T0S26…Model No: 190766; UDI-DI: 00840861100910; Serial No. 1T0S261032, 1T0S261004, 1T0S261029, 1T0S260995, 1T0S260937, 1T0S260739, 1T0S260687, 1T0S260573, 2T0S263945, 2T0S263947, 2T0S263959, 2T0S263924, 2T0S263962, 2T0S263956, 2T0S263951, 2T0S263950, 2T0S263707, 2T0S263692, 2T0S263690, 2T0S263682, 2T0S263700, 2T0S264084, 2T0S263944, 2T0S263954, 2T0S263957, 2T0S264087, 2T0S264144, 2T0S264132, 2T0S264073, 2T0S264139, 2T0S264061, 2T0S263979, 2T0S263983, 2T0S263973, 2T0S263977, 2T0S263989, 2T0S263938, 2T0S263960, 2T0S263943, 2T0S263968, 2T0S263941, 2T0S263940, 2T0S263939, 2T0S263934, 2T0S263933, 2T0S263932, 2T0S263931, 2T0S263930, 2T0S263927, 2T0S263926, 2T0S263925, 2T0S263923, 2T0S263922, 2T0S263921, 2T0S263920, 2T0S263919, 2T0S263918, 2T0S263916, 2T0S263912, 2T0S263911, 2T0S263910, 2T0S263792, 2T0S263791, 2T0S263784, 2T0S263780, 2T0S263778, 2T0S263776, 2T0S263775, 2T0S263771, 2T0S263769, 2T0S263767, 2T0S263754, 2T0S263752, 2T0S263721, 2T0S263715, 2T0S263711, 2T0S263703, 2T0S263948, 2T0S263718, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Other recalls by Fresenius Medical Care Holdings
- 5008X Blood Tubing Set, 24 units per case
FDA Device · Class II · 2026-07-15 · Fresenius Medical Care Holdings - Bicarby" Dialysate
FDA Device · Class II · 2026-06-17 · Fresenius Medical Care Holdings - Bicarby Dialysate
FDA Device · Class II · 2026-06-17 · Fresenius Medical Care Holdings - DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 1.5% DEX. LM/LC, 2L…
FDA Drug · Class II · 2026-05-13 · Fresenius Medical Care Holdings - DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 2.5% DEX. LM/LC, 2L…
FDA Drug · Class II · 2026-05-13 · Fresenius Medical Care Holdings
All Fresenius Medical Care Holdings recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0030-2024%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.