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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82729

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

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Event summary

Timeline bucket
April 03, 2019
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Fresenius Medical Care Renal Therapies Group, LLC

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

2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 191126 - Product Usage: The 2008T hemodialysis machine is indicated for acute and chronic dialysis therapy in a healthcare facility.

Z-1699-2019
Recall number
Z-1699-2019
Initiated
April 03, 2019
Classification
Class III
Status
Terminated
Quantity
257 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Power Logic Board Fail Message on the 2008T BlueStar Machine with software version 2.72.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Power Logic Board Fail Message on the 2008T BlueStar Machine with software version 2.72.

Code information

Software v.2.72

Distribution pattern

US Nationwide distribution.