Recall events
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Event 94084
Event summary
Timeline bucket January 23, 2024
Product types Device
Classifications Class I
Statuses Ongoing
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
5 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 5
stay-safe /Safe Lock Catheter Ext. 12 in
Z-1323-2024
Recall number Z-1323-2024
Initiated January 23, 2024
Classification Class I
Status Ongoing
Quantity 114,982 eaches
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
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-1323-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[10146]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
Code information Model Number: 050-95001; UDI/DI (Bag): 00840861100767; UDI/DI (Case): 10840861100764; All lots.
Distribution pattern Domestic: Nationwide Distribution.
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[36426]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 5
stay-safe /Luer Lock Adapter 4 in
Z-1324-2024
Recall number Z-1324-2024
Initiated January 23, 2024
Classification Class I
Status Ongoing
Quantity 828,954 eaches
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
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-1324-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[46423]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
Code information Model Number: 050-95003; UDI/DI (Bag): 00840861100774; UDI/DI (Case): 10840861100771; All lots.
Distribution pattern Domestic: Nationwide Distribution.
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[36395]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 5
stay-safe /Luer Lock Catheter Ext. 12 in
Z-1325-2024
Recall number Z-1325-2024
Initiated January 23, 2024
Classification Class I
Status Ongoing
Quantity 663,221 eaches
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
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-1325-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[34908]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
Code information Model Number: 050-95004; UDI/DI (Bag): 00840861100781; UDI/DI (Case): 10840861100788; All lots.
Distribution pattern Domestic: Nationwide Distribution.
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[37037]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 5
stay-safe /Luer Lock Catheter Ext. 18 in
Z-1326-2024
Recall number Z-1326-2024
Initiated January 23, 2024
Classification Class I
Status Ongoing
Quantity 479,978 eaches
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
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-1326-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[28883]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
Code information Model Number: 050-95005; UDI/DI (Bag): 00840861100798; UDI/DI (Case): 10840861100795; All lots.
Distribution pattern Domestic: Nationwide Distribution.
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[36401]
FDA event record
· Exact recall-number query on openFDA
device · product 5 of 5
stay-safe /Luer Catheter Ext. 6 in
Z-1327-2024
Recall number Z-1327-2024
Initiated January 23, 2024
Classification Class I
Status Ongoing
Quantity 105,700 eaches
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
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-1327-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[5522]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
Code information Model Number: 050-95013; UDI/DI (Bag): 00840861100804; UDI/DI (Case): 10840861100801; All lots.
Distribution pattern Domestic: Nationwide Distribution.
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[36928]
FDA event record
· Exact recall-number query on openFDA
