Fresenius Medical Care Renal Therapies Group, LLC: Medical Device Recall in 2018 - (Recall #: Z-0516-2019)

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:

Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL Catalog Number: OFD2201-3B for hemodialysis

Product Classification:

Class III

Date Initiated: October 9, 2018

Date Posted: December 5, 2018

Recall Number: Z-0516-2019

Event ID: 81451

Reason for Recall:

Discolored powder has confirmed the presence of a foreign substance

Status: Terminated

Product Quantity: 4752

Code Information:

Lot code:18ETGF005

Distribution Pattern:

Distribution US nationwide and Mexico

Voluntary or Mandated:

Voluntary: Firm initiated