Rockwell Medical, Inc: Medical Device Recall in 2018 - (Recall #: Z-1869-2018)

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:

DriSate¿ Product Code DR-145 The acid concentrate powders and liquids are indicated for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine/monitor and bicarbonate concentrate.

Product Classification:

Class II

Date Initiated: April 7, 2018

Date Posted: May 23, 2018

Recall Number: Z-1869-2018

Event ID: 79878

Reason for Recall:

A subassembly component (dextrose bag) within this case product contained small amounts of sodium bicarbonate from a prior batch.

Status: Terminated

Product Quantity: 139

Code Information:

Lot 28562-0220171

Distribution Pattern:

US Distribution to the state of NY

Voluntary or Mandated:

Voluntary: Firm initiated