Recall events
/
Event 79195
Event summary
Timeline bucket October 13, 2017
Product types Device
Classifications Class II
Statuses Terminated
Recalling firm wording Cook 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
20 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 20
Amplatz Extra Stiff Whisker Wire Guide
Z-0947-2018
Recall number Z-0947-2018
Initiated October 13, 2017
Classification Class II
Status Terminated
Quantity 648
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Label does not state
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Labeling Change Control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0947-2018
Source locator 0001-device-recall-0001-of-0001.json.zip#results[51398]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Label does not state that the product is heparin-coated.
Code information Catalog # THSCF-35-260-3-AESW-BH Affected lot codes range from: 3733552 - 6175191 F3729974 - F4923948 NS4927345 - NS6177894
Distribution pattern Nationally
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[8382]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 20
Amplatz Extra Stiff Wire Guide
Z-0948-2018
Recall number Z-0948-2018
Initiated October 13, 2017
Classification Class II
Status Terminated
Quantity 129,727
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Label does not state
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Labeling Change Control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0948-2018
Source locator 0001-device-recall-0001-of-0001.json.zip#results[38595]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Label does not state that the product is heparin-coated.
Code information Catalog # THSCF / AES-BH THSF / AES-BH Affected lot codes range from: 3730001 - 6164916 F3729969 - F4922979 NS4928020 - NS6203182 Affected lot codes range from: 3733552 - 6175191 F3729974 - F4923948 NS4927345 - NS6177894
Distribution pattern Nationally
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[10504]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 20
Amplatz Stiff Wire Guide
Z-0949-2018
Recall number Z-0949-2018
Initiated October 13, 2017
Classification Class II
Status Terminated
Quantity 32,340
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Label does not state
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Labeling Change Control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0949-2018
Source locator 0001-device-recall-0001-of-0001.json.zip#results[34587]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Label does not state that the product is heparin-coated.
Code information Catalog # THSF / ASG-BH Affected lot codes range from: 3730001 - 6164916 F3729969 - F4922979 NS4928020 - NS6203182
Distribution pattern Nationally
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[9642]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 20
Amplatz Ultra Stiff Wire Guide
Z-0950-2018
Recall number Z-0950-2018
Initiated October 13, 2017
Classification Class II
Status Terminated
Quantity 12,462
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Label does not state
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Labeling Change Control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0950-2018
Source locator 0001-device-recall-0001-of-0001.json.zip#results[15071]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Label does not state that the product is heparin-coated.
Code information Catalog # THSF / ASG-BH Affected lot codes range from: 3730001 - 6164916 F3729969 - F4922979 NS4928020 - NS6203182 Affected lot codes range from: 3733552 - 6175191 F3729974 - F4923948 NS4927345 - NS6177894
Distribution pattern Nationally
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[9588]
FDA event record
· Exact recall-number query on openFDA
device · product 5 of 20
Bentson Cerebral Wire Guide
Z-0951-2018
Recall number Z-0951-2018
Initiated October 13, 2017
Classification Class II
Status Terminated
Quantity 45
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Label does not state
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Labeling Change Control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0951-2018
Source locator 0001-device-recall-0001-of-0001.json.zip#results[20728]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Label does not state that the product is heparin-coated.
Code information Catalog # THSFB-35-145-BH Affected lots to include: F3813488 - F4859795 NS5327890 - NS6060291
Distribution pattern Nationally
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[8394]
FDA event record
· Exact recall-number query on openFDA
device · product 6 of 20
Bentson Plus Wire Guide
Z-0952-2018
Recall number Z-0952-2018
Initiated October 13, 2017
Classification Class II
Status Terminated
Quantity 8,147
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Label does not state
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Labeling Change Control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0952-2018
Source locator 0001-device-recall-0001-of-0001.json.zip#results[15078]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Label does not state that the product is heparin-coated.
Code information Catalog # TSFBP- / -BH Affected lots include: 3771080 - 5942053 F4265639
Distribution pattern Nationally
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[8834]
FDA event record
· Exact recall-number query on openFDA
device · product 7 of 20
Bentson Wire Guide
Z-0953-2018
Recall number Z-0953-2018
Initiated October 13, 2017
Classification Class II
Status Terminated
Quantity 439,797
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Label does not state
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Labeling Change Control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0953-2018
Source locator 0001-device-recall-0001-of-0001.json.zip#results[38601]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Label does not state that the product is heparin-coated.
Code information Catalog # TSFB-/-BH Affected lots include: F3813488 - F4859795 NS5327890 - NS6060291 3730884 - 5984142 F3746894 - F4920488 NS4937520 - NS6252870
Distribution pattern Nationally
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[9442]
FDA event record
· Exact recall-number query on openFDA
device · product 8 of 20
Coons Interventional Wire Guide
Z-0954-2018
Recall number Z-0954-2018
Initiated October 13, 2017
Classification Class II
Status Terminated
Quantity 3,369
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Label does not state
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Labeling Change Control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0954-2018
Source locator 0001-device-recall-0001-of-0001.json.zip#results[34579]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Label does not state that the product is heparin-coated.
Code information Catalog # THSF-/-COONS-BH Affected lot codes range from: 3730001 - 6164916 F3729969 - F4922979 NS4928020 - NS6203182
Distribution pattern Nationally
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[9486]
FDA event record
· Exact recall-number query on openFDA
device · product 9 of 20
Disposable Reuter Tip Deflecting Wire Guide
Z-0955-2018
Recall number Z-0955-2018
Initiated October 13, 2017
Classification Class II
Status Terminated
Quantity 18,398
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Label does not state
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Labeling Change Control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0955-2018
Source locator 0001-device-recall-0001-of-0001.json.zip#results[56900]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Label does not state that the product is heparin-coated.
Code information Catalog # DTDW-/-BW Affected lots to include: 3730008 - 6164931 F4374635 - F4791430 NS5034700 - NS5562947
Distribution pattern Nationally
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[9551]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0956-2018
Initiated October 13, 2017
Classification Class II
Status Terminated
Quantity 10,367
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Label does not state
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Labeling Change Control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0956-2018
Source locator 0001-device-recall-0001-of-0001.json.zip#results[38594]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Label does not state that the product is heparin-coated.
Code information Catalog # DTDW-/-BW Affected lots include: F3749839 - F4849938 NS5085893 - NS5827127 F4628078 - F4856722 3763189 - 6106860 F3739663 - F4916737 NS4980257 - NS6098990
Distribution pattern Nationally
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[9568]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0957-2018
Initiated October 13, 2017
Classification Class II
Status Terminated
Quantity 2,210
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Label does not state
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Labeling Change Control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0957-2018
Source locator 0001-device-recall-0001-of-0001.json.zip#results[45862]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Label does not state that the product is heparin-coated.
Code information Catalog # TSCFB-/-BH Affected lots range from: F3734676 - F4911986 NS4938980 - NS6144078
Distribution pattern Nationally
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[10344]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0958-2018
Initiated October 13, 2017
Classification Class II
Status Terminated
Quantity 601,778
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Label does not state
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Labeling Change Control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0958-2018
Source locator 0001-device-recall-0001-of-0001.json.zip#results[34624]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Label does not state that the product is heparin-coated.
Code information Catalog # C-SCF-/-BH C-SF-/-BH SF-/-BH THSCF-/-BH THSF-/-BH TSCF-/-BH TSCFR-/-BH TSF-/-BH Affected lot codes range from: 3730001 - 6164916 F3729969 - F4922979 NS4928020 - NS6203182 Affected lot codes range from: 3733552 - 6175191 F3729974 - F4923948 NS4927345 - NS6177894 F3753452 - F4925547 NS5008794 - NS6171324 F3922830 - F4218188 NS5470403 - NS6020850 F4087814 - F4741344 NS4929840 - NS5104065 F4119548 - F4920483 NS5171771 - NS6144080 3730875 - 6180567 F3730082 - F4924418 NS4928022 - NS6177724 NS5185993 3730101 - 6181269 F3734860 - F4923958 NS4927349 - NS6203187
Distribution pattern Nationally
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[8379]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0959-2018
Initiated October 13, 2017
Classification Class II
Status Terminated
Quantity 21,913
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Label does not state
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Labeling Change Control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0959-2018
Source locator 0001-device-recall-0001-of-0001.json.zip#results[3158]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Label does not state that the product is heparin-coated.
Code information Catalog # TCMTNA-/-BH TMT-/-BH TSFNA-/-BH Affected lots range from: 3774481 - 6145673 F3876320 - F4894841 NS4963396 - NS5144675 F4608907 3758468 - 6167814
Distribution pattern Nationally
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[9480]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0960-2018
Initiated October 13, 2017
Classification Class II
Status Terminated
Quantity 41,113
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Label does not state
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Labeling Change Control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0960-2018
Source locator 0001-device-recall-0001-of-0001.json.zip#results[34578]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Label does not state that the product is heparin-coated.
Code information Catalog #THSCFNB-/-BH TSCFNA-BH TSCFNB-/-BH TSFNA-/-BH TSFNB-/-BH Affected lots range from: 3733537 - 5803299 F3762971 - F4692445 NS5043714 - NS5900771 3766161 - 5925080 F3753484 - F4887253 NS4938982 - NS5932560 F4556472 - F4718761 NS6024246 3741877 - 5929842 F3749985 - F4903656 NS4928037 - NS5963186 3744567 - 6253002 F3763300 - F4900931 NS4928039 - NS59824 3741882 - 6142463 F3884311 - F4903643 NS5044201 - NS5963180
Distribution pattern Nationally
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[9407]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0961-2018
Initiated October 13, 2017
Classification Class II
Status Terminated
Quantity 55
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Label does not state
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Labeling Change Control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0961-2018
Source locator 0001-device-recall-0001-of-0001.json.zip#results[51402]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Label does not state that the product is heparin-coated.
Code information Catalog # TDW-/-SGH-BH Affected lots to include: F4423853 - F4898351 NS5072022 - NS6166764
Distribution pattern Nationally
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[10492]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0962-2018
Initiated October 13, 2017
Classification Class II
Status Terminated
Quantity 98,502
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Label does not state
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Labeling Change Control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0962-2018
Source locator 0001-device-recall-0001-of-0001.json.zip#results[20734]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Label does not state that the product is heparin-coated.
Code information Catalog # TDW-/-SGH-BH Affected lot codes range from: 3733552 - 6175191 F3729974 - F4923948 NS4927345 - NS6177894
Distribution pattern Nationally
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[7775]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0963-2018
Initiated October 13, 2017
Classification Class II
Status Terminated
Quantity 3,364
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Label does not state
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Labeling Change Control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0963-2018
Source locator 0001-device-recall-0001-of-0001.json.zip#results[27638]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Label does not state that the product is heparin-coated.
Code information Catalog # TSCFNB-35-180-SPENCERMOD- BH Affected lots to include: 3741882 - 6142463 F3884311 - F4903643 NS5044201 - NS5963180
Distribution pattern Nationally
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[9611]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0964-2018
Initiated October 13, 2017
Classification Class II
Status Terminated
Quantity 13
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Label does not state
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Labeling Change Control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0964-2018
Source locator 0001-device-recall-0001-of-0001.json.zip#results[38599]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Label does not state that the product is heparin-coated.
Code information Catalog # TSCFNB-35-180-SPENCERMOD- BH ALL LOTS
Distribution pattern Nationally
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[9635]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0965-2018
Initiated October 13, 2017
Classification Class II
Status Terminated
Quantity 56
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Label does not state
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Labeling Change Control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0965-2018
Source locator 0001-device-recall-0001-of-0001.json.zip#results[20732]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Label does not state that the product is heparin-coated.
Code information Catalog # C-ULAP-5.0-60-DTK-BH ALL LOTS
Distribution pattern Nationally
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[9560]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0966-2018
Initiated October 13, 2017
Classification Class II
Status Terminated
Quantity 266
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Label does not state
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Labeling Change Control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0966-2018
Source locator 0001-device-recall-0001-of-0001.json.zip#results[27640]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Label does not state that the product is heparin-coated.
Code information Catalog # C-PMS-300-CHILDRENS-A- 032988 ALL LOTS
Distribution pattern Nationally
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[9651]
FDA event record
· Exact recall-number query on openFDA
