Fresenius Medical Care Renal Therapies Group, LLC: Medical Device Recall in 2018 - (Recall #: Z-0658-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E

Product Classification:

Class II

Date Initiated: November 5, 2018

Date Posted: December 26, 2018

Recall Number: Z-0658-2019

Event ID: 81598

Reason for Recall:

Potential for external blood leaks from the dialyzer header

Status: Terminated

Product Quantity: 9,097 cs x 12 units each

Code Information:

Lot Numbers: 18HU06016, 18HU06017, 18HU06018 and 18HU06019

Distribution Pattern:

US Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated