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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76037

4 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 21, 2016
Product types
Device
Classifications
Class II
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

4 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 4

Fresenius 2008T Series Hemodialysis System

Z-1026-2017
Recall number
Z-1026-2017
Initiated
December 21, 2016
Classification
Class II
Status
Terminated
Quantity
65361 units (US) 249 units (OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled UF Rate is actually being executed rather than rate displayed on the machine

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled UF Rate is actually being executed rather than rate displayed on the machine

Code information

All serial numbers

Distribution pattern

Nationwide Foreign: Canada, Mexico, Jamaica, Germany, Guam

device · product 2 of 4

Fresenius 2008K Series : Hemodialysis System

Z-1027-2017
Recall number
Z-1027-2017
Initiated
December 21, 2016
Classification
Class II
Status
Terminated
Quantity
78481 (US) 2734 units (OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled UF Rate is actually being executed rather than rate displayed on the machine

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled UF Rate is actually being executed rather than rate displayed on the machine

Code information

All serial numbers

Distribution pattern

Nationwide Foreign: Canada, Mexico, Jamaica, Germany, Guam

device · product 3 of 4

Fresenius 2008K2 Series : Hemodialysis System

Z-1028-2017
Recall number
Z-1028-2017
Initiated
December 21, 2016
Classification
Class II
Status
Terminated
Quantity
60,151 units (US) 1773 (OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled UF Rate is actually being executed rather than rate displayed on the machine

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled UF Rate is actually being executed rather than rate displayed on the machine

Code information

All serial numbers

Distribution pattern

Nationwide Foreign: Canada, Mexico, Jamaica, Germany, Guam

device · product 4 of 4

Fresenius 2008K@home Series : Hemodialysis System

Z-1029-2017
Recall number
Z-1029-2017
Initiated
December 21, 2016
Classification
Class II
Status
Terminated
Quantity
1400 units (US) 556 units (OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled UF Rate is actually being executed rather than rate displayed on the machine

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled UF Rate is actually being executed rather than rate displayed on the machine

Code information

All serial numbers

Distribution pattern

Nationwide Foreign: Canada, Mexico, Jamaica, Germany, Guam