Fresenius Medical Care Holdings, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1827-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

NaturaLyte Liquid Bicarbonate Concentrate (Dialysate Concentrate for Hemodialysis (liquid), 6.4 Liter Bottle Catalog Number: 08-4000-LB This concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates.

Product Classification:

Class II

Date Initiated: May 20, 2015

Date Posted: July 1, 2015

Recall Number: Z-1827-2015

Event ID: 71160

Reason for Recall:

Bacterial contamination.

Status: Ongoing

Product Quantity: 1,856,619 Bottles

Code Information:

Affected lots begin with: 14DMLB, 14EMLB, 14HMLB, 14JMLB, 14KMLB, 14LMBL, 14NMLB, 14PMLB, and 14SMLB.

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated