Recall events
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Event 68042
Event summary
Timeline bucket April 25, 2014
Product types Device
Classifications Class II
Statuses Terminated
Recalling firm wording Fresenius Medical Care Holdings, 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
2 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 2
Fresenius 2008T Hemodialysis Machine with Revision K Actuator Test Boards and also sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Machines (2008K, 2008K2, 2008K@home and 2008T). Part Number: 190234 Revision K
Z-1618-2014
Recall number Z-1618-2014
Initiated April 25, 2014
Classification Class II
Status Terminated
Quantity 79 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
2008-Series Hemodialysis Machines with Revision K Actuator Test Boards may fail to detect a disconnected Ultrafiltration (UF) Pump
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Device Design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1618-2014
Source locator 0001-device-recall-0001-of-0001.json.zip#results[8025]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall 2008-Series Hemodialysis Machines with Revision K Actuator Test Boards may fail to detect a disconnected Ultrafiltration (UF) Pump
Code information Revision K Actuator Test Boards S/N of 2008 T Machines: 3T0S124903 3T0S124937 3T0S124933 3T0S124986 3T0S124934 3T0S124970 3T0S124894 3T0S124935 3T0S124912 3T0S124965 3T0S124944 3T0S124988 3T0S124939 3T0S124990 3T0S124940 3T0S124941 3T0S124958 3T0S124888 3T0S124946 3T0S124999 3T0S124942 3T0S124991 3T0S125023 3T0S124951 3T0S124936 3T0S124895 3T0S124955 3T0S125000 3T0S124943 3T0S125010 3T0S124893 3T0S124954 3T0S124896 3T0S124899 3T0S124959 3T0S125008 3T0S124947 3T0S125018 3T0S124905 3T0S124961 3T0S124898 3T0S124907 3T0S124963 3T0S124891 3T0S124952 3T0S125028 3T0S124920 3T0S124966 3T0S124910 3T0S124909 3T0S124967 3T0S124901 3T0S124953 3T0S125029 3T0S124922 3T0S124969 3T0S124913 3T0S124911 3T0S124972 3T0S124902 3T0S124960 3T0S124930 3T0S124925 3T0S125011 3T0S124921 3T0S124916 3T0S124979 3T0S124918 3T0S124962 3T0S124945 3T0S124926 3T0S125013 3T0S124927 3T0S124917 3T0S124984 3T0S124928 3T0S124968 3T0S124964 3T0S124932
Distribution pattern USA (nationwide) and the country of Canada.*
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[10239]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 2
Revision K Actuator Test Boards sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Machines (2008K, 2008K2, 2008K@home and 2008T). Part Number: 190713 Revision K
Z-1619-2014
Recall number Z-1619-2014
Initiated April 25, 2014
Classification Class II
Status Terminated
Quantity 39 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
2008-Series Hemodialysis Machines with Revision K Actuator Test Boards may fail to detect a disconnected Ultrafiltration (UF) Pump
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Device Design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1619-2014
Source locator 0001-device-recall-0001-of-0001.json.zip#results[18521]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall 2008-Series Hemodialysis Machines with Revision K Actuator Test Boards may fail to detect a disconnected Ultrafiltration (UF) Pump
Code information Revision K Actuator Test Boards
Distribution pattern USA (nationwide) and the country of Canada.*
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[13186]
FDA event record
· Exact recall-number query on openFDA
