Fresenius Medical Care Renal Therapies Group, LLC: Medical Device Recall in 2016 - (Recall #: Z-1324-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Fresenius Hemoflow F3 Dialyzer Part Number: 0520165A Indicated for Acute and Chronic Hemodialysis

Product Classification:

Class II

Date Initiated: February 26, 2016

Date Posted: April 13, 2016

Recall Number: Z-1324-2016

Event ID: 73387

Reason for Recall:

Dialyzer header leak due to possible improper torque

Status: Terminated

Product Quantity: 1,650 units

Code Information:

Lot Number: 15KU04011 Exp. Date : 08/31/2013

Distribution Pattern:

US Nationwide Distribution including states of: AZ, CA, CT, DC, GA, IL, IN, MI, MN, MO, MS, NY, OH, PA, SC, SD, TX, and WA.

Voluntary or Mandated:

Voluntary: Firm initiated