Fresenius Medical Care Holdings, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1739-2014)

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:

NaturaLyte¿ Liquid Bicarbonate Concentrate, 6.4 liter bottle to be used with a hemodialysis unit; Part Number: 08-4000-LB. The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates.

Product Classification:

Class III

Date Initiated: May 1, 2014

Date Posted: June 18, 2014

Recall Number: Z-1739-2014

Event ID: 68135

Reason for Recall:

Container cap may contain foreign material- 0.60% - 0.80% Manganese

Status: Terminated

Product Quantity: 12 bottles

Code Information:

Lot Number: 14CMLB006

Distribution Pattern:

Distributed in the state of MO.

Voluntary or Mandated:

Voluntary: Firm initiated