Home / Recalls / Fresenius Medical Care Holdings, Inc. / Z-0801-2025

Z-0801-2025 Class II Ongoing

Recalled by Fresenius Medical Care Holdings, Inc. — Waltham, MA

Recall Details

Product Type
Devices
Report Date
January 15, 2025
Initiation Date
December 5, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5,351 cases (64,212 dialyzers)

Product Description

Dialyzer Optiflux 160NRe

Reason for Recall

Potential for internal blood leaks due to cracked polyurethane

Distribution Pattern

Nationwide Distribution.

Code Information

UDI NUMBERS: 24HU06011-00840861100149-270630, 24HU06010-00840861100149-270630. Expiration date: 06/30/2027.

Other recalls by Fresenius Medical Care Holdings, Inc.

  • Z-0936-2026 Class II — 5008X CAREsystem +CLiC +CDX; (October 25, 2025)
  • Z-0041-2026 Class II — Optiflux¿ High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NR (August 29, 2025)
  • D-0490-2025 Class II — 0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Freseni (May 27, 2025)
  • Z-1992-2025 Class II — 5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following m (April 29, 2025)
  • Z-3124-2024 Class II — Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with f (August 8, 2024)
  • D-0608-2024 Class II — DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXT (June 18, 2024)
  • Z-2347-2024 Class II — RTLR190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare par (June 3, 2024)
  • Z-2345-2024 Class II — RTL190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model N (June 3, 2024)
  • Z-2344-2024 Class II — RTL190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part (June 3, 2024)
  • Z-2343-2024 Class II — 190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, M (June 3, 2024)