Fresenius Medical Care Holdings, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1099-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Optiflux F160NR High Flux Dialyzers; Product Number: 0500316N. Single Use acute or chronic hemanalysis treatment.

Product Classification:

Class II

Date Initiated: February 4, 2014

Date Posted: March 5, 2014

Recall Number: Z-1099-2014

Event ID: 67313

Reason for Recall:

Dialysate Port Leak During Priming of the Dialyzers

Status: Terminated

Product Quantity: 6720 units

Code Information:

Lot Numbers: 13NU01014 13SU01001 13SU01002

Distribution Pattern:

Worldwide distribution: USA (nationwide) and the country of: Mexico.

Voluntary or Mandated:

Voluntary: Firm initiated