Fresenius Medical Care Renal Therapies Group, LLC: Medical Device Recall in 2016 - (Recall #: Z-0887-2016)

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 Naturalyte Liquid Acid Concentrate Catalog Number: 08-2301-3 Intended Use: Acid Concentrate for Bicarbonate Dialysis

Product Classification:

Class II

Date Initiated: January 18, 2016

Date Posted: March 2, 2016

Recall Number: Z-0887-2016

Event ID: 73077

Reason for Recall:

On the label calcium (Ca) listed in the right upper corner of the label (red background) incorrectly indicates the product contains 2.5 mEq/L Ca. The concentration indicated in the list of constituents represents the actual calcium concentration of the final dialysate, 3.0 mEq/L.

Status: Terminated

Product Quantity: 848 (212 cases)

Code Information:

Lot Number: 15STAC072 Exp Date: 2017-12-31

Distribution Pattern:

US Distribution to states of: KS, LA, MS, OK, and TX.

Voluntary or Mandated:

Voluntary: Firm initiated