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.

Recall Insight

This FDA Devices action (record #Z-1869-2018) was formally reported on May 23, 2018, with the manufacturer initiating the action on April 7, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Rockwell Medical, Inc is listed as the recalling firm, operating out of Wixom, MI. Federal records indicate 139 units are affected.

The documented reason for this recall is: A subassembly component (dextrose bag) within this case product contained small amounts of sodium bicarbonate from a prior batch. Distribution data in the federal record shows the product reached: US Distribution to the state of NY. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC and NHTSA going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 8 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.