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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79878

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 07, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Rockwell Medical, Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-1869-2018
Recall number
Z-1869-2018
Initiated
April 07, 2018
Classification
Class II
Status
Terminated
Recalling firm
Rockwell Medical, Inc
Quantity
139

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A subassembly component (dextrose bag) within this case product contained small amounts of sodium bicarbonate from a prior batch.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Lot 28562-0220171

Distribution pattern

US Distribution to the state of NY