The Recall Desk

Manufacturer

Rockwell Medical, Inc

1 recall in our database name Rockwell Medical, Inc as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2018-05-23

Of the 1 recalls from Rockwell Medical, Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–1 of 1

  • ModerateFDA (Devices)·Z-1869-2018·2018-05-23

    Rockwell Medical Recalls DriSate Hemodialysis Acid Concentrate Due to Contamination

    Rockwell Medical is recalling DriSate hemodialysis acid concentrate because a subassembly component contained small amounts of sodium bicarbonate from a prior batch.

    Product
    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.
    Category
    Medical Device
    Distribution
    1 state