Recall events
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Event 67313
Event summary
Timeline bucket February 04, 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
9 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 9
Optiflux F160NRe High Flux Dialyzers; Product Number: 0500316E. Single Use acute or chronic hemanalysis treatment.
Z-1098-2014
Recall number Z-1098-2014
Initiated February 04, 2014
Classification Class II
Status Terminated
Quantity 3,460,672 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Dialysate Port Leak During Priming of the Dialyzers
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1098-2014
Source locator 0001-device-recall-0001-of-0001.json.zip#results[14244]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Dialysate Port Leak During Priming of the Dialyzers
Code information Lot Numbers: 13LU01001 13KU05018 13LU05001 13KU06026 13LU06001 13LU06002 13LU05002 13LU06003 13LU01007 13LU01008 13LU01009 13LU05003 13LU05004 13LU05005 13LU05006 13LU05007 13LU05008 13LU06004 13LU06005 13LU06006 13LU06008 13LU06009 13LU06010 13LU06011 13LU06012 13LU06013 13LU06014 13LU06015 13LU06016 13LU01010 13LU01011 13LU06017 13LU06018 13LU01012 13LU01013 13LU05014 13LU06019 13LU06020 13LU06021 13LU01015 13LU05015 13LU06022 13NU05002 13NU06002 13NU01004 13NU05003 13NU06003 13NU06004 13NU06007 13NU01005 13NU01006 13NU01007 13NU01008 13NU06008 13NU06009 13NU06010 13NU06011 13NU06012 13NU06013 13NU06014 13NU01009 13NU01010 13NU06015 13NU06016 13NU06017 13NU06018 13NU06020 13NU06021 13NU06022 13NU06023 13NU06024 13NU06025 13NU06026 13NU06027 13NU01015 13NU01016 13NU01017 13NU01018 13PU01001 13PU01002 13PU01003 13NU06029 13PU06001 13PU06002 13PU06018 13PU01013 13PU01014 13PU01015 13PU01017 13PU06019 13PU06020 13PU06021 13PU06022 13PU06023 13PU06024 13PU06025 13PU06026 13PU06027 13PU06028 13SU06004 13SU06005 13LU06023 13LU06024 13LU06025 13LU06027 13LU06028 13NU06001 13LU05016 13LU01016 13LU01017 13NU01001 13LU05017 13NU01002 13PU06003 13PU01004 13PU01007 13PU06006 13PU06007 13PU01008 13PU01010 13PU01011 13PU01012 13PU06015 13PU06016 13PU06017
Distribution pattern Worldwide distribution: USA (nationwide) and the country of: Mexico.
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[10583]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 9
Optiflux F160NR High Flux Dialyzers; Product Number: 0500316N. Single Use acute or chronic hemanalysis treatment.
Z-1099-2014
Recall number Z-1099-2014
Initiated February 04, 2014
Classification Class II
Status Terminated
Quantity 6720 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Dialysate Port Leak During Priming of the Dialyzers
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1099-2014
Source locator 0001-device-recall-0001-of-0001.json.zip#results[18428]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Dialysate Port Leak During Priming of the Dialyzers
Code information Lot Numbers: 13NU01014 13SU01001 13SU01002
Distribution pattern Worldwide distribution: USA (nationwide) and the country of: Mexico.
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[10595]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 9
Optiflux F180NRe High Flux Dialyzers; Product Number: 0500318E. Single Use acute or chronic hemanalysis treatment.
Z-1100-2014
Recall number Z-1100-2014
Initiated February 04, 2014
Classification Class II
Status Terminated
Quantity 3,744,122
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Dialysate Port Leak During Priming of the Dialyzers
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1100-2014
Source locator 0001-device-recall-0001-of-0001.json.zip#results[24204]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Dialysate Port Leak During Priming of the Dialyzers
Code information Lot Numbers: 13LU02004 13LU02005 13LU02008 13LU03006 13LU03007 13LU03008 13LU04005 13LU04006 13LU04007 13LU04008 13LU04009 13LU04010 13LU03009 13LU03010 13LU03011 13LU03012 13LU04011 13LU04012 13LU03014 13LU02018 13LU03015 13LU03016 13LU03017 13LU03018 13NU03001 13NU02001 13NU03002 13NU03004 13NU03005 13NU02005 13NU02006 13NU02007 13NU03006 13NU03007 13NU03008 13NU03009 13NU05006 13NU05007 13NU05009 13NU03011 13NU03012 13NU04011 13NU05016 13NU05017 13NU05018 13NU03018 13NU04017 13PU02003 13NU03019 13PU03001 13PU03002 13PU03003 13PU05002 13PU05003 13PU02004 13PU02005 13PU02006 13PU02007 13PU03004 13PU03006 13PU03007 13PU03008 13PU05004 13PU02010 13PU02011 13PU02012 13PU03010 13PU04011 13PU04012 13PU04013 13PU05009 13PU05010 13PU05011 13PU02013 13PU02014 13PU02015 13PU02016 13PU02017 13PU03013 13PU03014 13PU03015 13PU03016 13PU03017 13PU04014 13PU05016 13PU05017 13SU05001 13SU02003 13SU03004 13SU02004 13NU04012 13NU05010 13NU05011 13NU02012 13NU02013 13NU02014 13NU03016 13NU03017 13NU04015 13NU04016 13NU05014 13NU05015 13PU04015 13PU04016 13PU04017 13PU04018 13PU05012 13PU05013 13PU05014 13PU05015 13PU02018 13PU02019 13SU02001 13PU04019
Distribution pattern Worldwide distribution: USA (nationwide) and the country of: Mexico.
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[10465]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 9
Optiflux F180NR High Flux Dialyzers; Product Number: 0500318N. Single Use acute or chronic hemanalysis treatment.
Z-1101-2014
Recall number Z-1101-2014
Initiated February 04, 2014
Classification Class II
Status Terminated
Quantity 52,752 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Dialysate Port Leak During Priming of the Dialyzers
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1101-2014
Source locator 0001-device-recall-0001-of-0001.json.zip#results[31117]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Dialysate Port Leak During Priming of the Dialyzers
Code information Lot Numbers: 13NU03003 13NU03010 13PU04010 13SU03001
Distribution pattern Worldwide distribution: USA (nationwide) and the country of: Mexico.
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[12478]
FDA event record
· Exact recall-number query on openFDA
device · product 5 of 9
Optiflux F200NRe High Flux Dialyzers; Product Number: 0500320E. Single Use acute or chronic hemanalysis treatment.
Z-1102-2014
Recall number Z-1102-2014
Initiated February 04, 2014
Classification Class II
Status Terminated
Quantity 317,796 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Dialysate Port Leak During Priming of the Dialyzers
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1102-2014
Source locator 0001-device-recall-0001-of-0001.json.zip#results[18431]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Dialysate Port Leak During Priming of the Dialyzers
Code information Lot Numbers: 13LU04022 13LU04021 13NU04003 13NU04005 13NU04018 13SU04002
Distribution pattern Worldwide distribution: USA (nationwide) and the country of: Mexico.
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[10641]
FDA event record
· Exact recall-number query on openFDA
device · product 6 of 9
Optiflux F200NR High Flux Dialyzers; Product Number: 0500320N. Single Use acute or chronic hemanalysis treatment.
Z-1103-2014
Recall number Z-1103-2014
Initiated February 04, 2014
Classification Class II
Status Terminated
Quantity 19,596 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Dialysate Port Leak During Priming of the Dialyzers
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1103-2014
Source locator 0001-device-recall-0001-of-0001.json.zip#results[31121]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Dialysate Port Leak During Priming of the Dialyzers
Code information Lot Number: 13NU04008
Distribution pattern Worldwide distribution: USA (nationwide) and the country of: Mexico.
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[12955]
FDA event record
· Exact recall-number query on openFDA
device · product 7 of 9
Optiflux F200A High Flux Dialyzers; Product Number: 0500320A. Single Use acute or chronic hemanalysis treatment.
Z-1104-2014
Recall number Z-1104-2014
Initiated February 04, 2014
Classification Class II
Status Terminated
Quantity 5,244 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Dialysate Port Leak During Priming of the Dialyzers
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1104-2014
Source locator 0001-device-recall-0001-of-0001.json.zip#results[24206]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Dialysate Port Leak During Priming of the Dialyzers
Code information Lot Number: 13NU04009
Distribution pattern Worldwide distribution: USA (nationwide) and the country of: Mexico.
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[12957]
FDA event record
· Exact recall-number query on openFDA
device · product 8 of 9
Optiflux B200 Flux Dialyzers; Product Number: 0500325E. Single Use acute or chronic hemanalysis treatment.
Z-1105-2014
Recall number Z-1105-2014
Initiated February 04, 2014
Classification Class II
Status Terminated
Quantity 100,008 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Dialysate Port Leak During Priming of the Dialyzers
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1105-2014
Source locator 0001-device-recall-0001-of-0001.json.zip#results[24205]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Dialysate Port Leak During Priming of the Dialyzers
Code information Lot Numbers: 13LU02011 13LU02013 13NU02016 13NU02017
Distribution pattern Worldwide distribution: USA (nationwide) and the country of: Mexico.
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[12949]
FDA event record
· Exact recall-number query on openFDA
device · product 9 of 9
Optiflux F18Nre Flux Dialyzers; Product Number: 0500308E. Single Use acute or chronic hemanalysis treatment.
Z-1106-2014
Recall number Z-1106-2014
Initiated February 04, 2014
Classification Class II
Status Terminated
Quantity 34,752 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Dialysate Port Leak During Priming of the Dialyzers
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1106-2014
Source locator 0001-device-recall-0001-of-0001.json.zip#results[43120]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Dialysate Port Leak During Priming of the Dialyzers
Code information Lot Number: 13PU03011
Distribution pattern Worldwide distribution: USA (nationwide) and the country of: Mexico.
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[10616]
FDA event record
· Exact recall-number query on openFDA
