FDA Device recall Z-0658-2019
Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E
- FDA Device
- Class II
- terminated
- Published 2018-12-26
On 2018-12-26 the FDA classified a Class II recall of Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E by Fresenius Medical Care Renal Therapies Group, citing potential for external blood leaks from the dialyzer header.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0658-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-11-05 |
| Published | 2018-12-26 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Fresenius Medical Care Renal Therapies Group |
| Distribution | US |
Product
Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E
Reason
Potential for external blood leaks from the dialyzer header
Identifiers
| code_info | Lot Numbers: 18HU06016, 18HU06017, 18HU06018 and 18HU06019 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Other recalls by Fresenius Medical Care Renal Therapies Group
- CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors
FDA Device · Class II · 2026-09-30 · Fresenius Medical Care Renal Therapies Group - 5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3C
FDA Device · Class II · 2026-09-09 · Fresenius Medical Care Renal Therapies Group - 5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6
FDA Device · Class II · 2026-09-09 · Fresenius Medical Care Renal Therapies Group - NaturaLyte, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-1251-1, 08-2251-0, 08-2301-3, 08-3251-9, 08-3301-2, 1…
FDA Device · Class II · 2026-09-09 · Fresenius Medical Care Renal Therapies Group - GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B
FDA Device · Class II · 2026-09-09 · Fresenius Medical Care Renal Therapies Group
All Fresenius Medical Care Renal Therapies Group recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0658-2019%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.