FDA Device recall Z-1324-2016
Fresenius Hemoflow F3 Dialyzer Part Number: 0520165A Indicated for Acute and Chronic Hemodialysis
- FDA Device
- Class II
- terminated
- Published 2016-04-13
On 2016-04-13 the FDA classified a Class II recall of Fresenius Hemoflow F3 Dialyzer Part Number: 0520165A Indicated for Acute and Chronic Hemodialysis by Fresenius Medical Care Renal Therapies Group, citing dialyzer header leak due to possible improper torque.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1324-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-02-26 |
| Published | 2016-04-13 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Fresenius Medical Care Renal Therapies Group |
| Distribution | US |
Product
Fresenius Hemoflow F3 Dialyzer Part Number: 0520165A Indicated for Acute and Chronic Hemodialysis
Reason
Dialyzer header leak due to possible improper torque
Identifiers
| code_info | Lot Number: 15KU04011 Exp. Date : 08/31/2013 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1324-2016%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.