Recall events
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Event 70369
Event summary
Timeline bucket January 15, 2015
Product types Device
Classifications Class II
Statuses Terminated
Recalling firm wording Churchill Medical Systems, 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
12 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 12
6" Trifurcated Extension Set, Product Code: AMS-375-1 Accessory device used to administer medical fluids
Z-1467-2015
Recall number Z-1467-2015
Initiated January 15, 2015
Classification Class II
Status Terminated
Quantity 5,200
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Potential for leaking caused by insufficient bond between needleless device and female luer.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1467-2015
Source locator 0001-device-recall-0001-of-0001.json.zip#results[32405]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential for leaking caused by insufficient bond between needleless device and female luer.
Code information 1304035, 1407046, 1410111D
Distribution pattern Nationwide Distribution including TX, OH, NY, CA, UT, PA, MA, NY, VA, and IL.
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[11647]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 12
Bifircated Extension Set, Product Code: BN-828 Accessory device used to administer medical fluids
Z-1468-2015
Recall number Z-1468-2015
Initiated January 15, 2015
Classification Class II
Status Terminated
Quantity 100
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Potential for leaking caused by insufficient bond between needleless device and female luer.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1468-2015
Source locator 0001-device-recall-0001-of-0001.json.zip#results[24439]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential for leaking caused by insufficient bond between needleless device and female luer.
Distribution pattern Nationwide Distribution including TX, OH, NY, CA, UT, PA, MA, NY, VA, and IL.
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[12171]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 12
4" Microbore Double Lumen Set with Bionector, Product Code: BN-208 Accessory device used to administer medical fluids
Z-1469-2015
Recall number Z-1469-2015
Initiated January 15, 2015
Classification Class II
Status Terminated
Quantity 2350
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Potential for leaking caused by insufficient bond between needleless device and female luer.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1469-2015
Source locator 0001-device-recall-0001-of-0001.json.zip#results[32402]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential for leaking caused by insufficient bond between needleless device and female luer.
Code information 1303123 1305003 1305008 1305049 1306097
Distribution pattern Nationwide Distribution including TX, OH, NY, CA, UT, PA, MA, NY, VA, and IL.
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[14027]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 12
4" Microbore Trifurcated Ext set, Product Code: BN-308 Accessory device used to administer medical fluids
Z-1470-2015
Recall number Z-1470-2015
Initiated January 15, 2015
Classification Class II
Status Terminated
Quantity 2200
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Potential for leaking caused by insufficient bond between needleless device and female luer.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1470-2015
Source locator 0001-device-recall-0001-of-0001.json.zip#results[32403]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential for leaking caused by insufficient bond between needleless device and female luer.
Code information 1303120 1305002 1306099
Distribution pattern Nationwide Distribution including TX, OH, NY, CA, UT, PA, MA, NY, VA, and IL.
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[12136]
FDA event record
· Exact recall-number query on openFDA
device · product 5 of 12
4" Microbore T-Port Set, Product Code: BN-448 Accessory device used to administer medical fluids
Z-1471-2015
Recall number Z-1471-2015
Initiated January 15, 2015
Classification Class II
Status Terminated
Quantity 450
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Potential for leaking caused by insufficient bond between needleless device and female luer.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1471-2015
Source locator 0001-device-recall-0001-of-0001.json.zip#results[43344]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential for leaking caused by insufficient bond between needleless device and female luer.
Code information 1303181 1303100 1304183
Distribution pattern Nationwide Distribution including TX, OH, NY, CA, UT, PA, MA, NY, VA, and IL.
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[13021]
FDA event record
· Exact recall-number query on openFDA
device · product 6 of 12
8" Standard Bore Ext Set, Product Code: BN-481 Accessory device used to administer medical fluids
Z-1472-2015
Recall number Z-1472-2015
Initiated January 15, 2015
Classification Class II
Status Terminated
Quantity 0
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Potential for leaking caused by insufficient bond between needleless device and female luer.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1472-2015
Source locator 0001-device-recall-0001-of-0001.json.zip#results[32401]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential for leaking caused by insufficient bond between needleless device and female luer.
Code information 1304129 1305051
Distribution pattern Nationwide Distribution including TX, OH, NY, CA, UT, PA, MA, NY, VA, and IL.
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[11638]
FDA event record
· Exact recall-number query on openFDA
device · product 7 of 12
7" High Pressure Set with Bionector, Product Code: CMS-808 and CMS-808-1 Accessory device used to administer medical fluids
Z-1473-2015
Recall number Z-1473-2015
Initiated January 15, 2015
Classification Class II
Status Terminated
Quantity 129,500
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Potential for leaking caused by insufficient bond between needleless device and female luer.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1473-2015
Source locator 0001-device-recall-0001-of-0001.json.zip#results[8117]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential for leaking caused by insufficient bond between needleless device and female luer.
Code information 1303184 1304184 1305112 1306088 1309061 1311057 1312168 1401125 1402017 1403050 1404052 1405018 1405106 1406151 1407065 1408054 1409122D 1410064D 1410155D 1410156D
Distribution pattern Nationwide Distribution including TX, OH, NY, CA, UT, PA, MA, NY, VA, and IL.
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[14005]
FDA event record
· Exact recall-number query on openFDA
device · product 8 of 12
7" Standard Bore High Pressure Ext Set, Product Code: CMS-809 Accessory device used to administer medical fluids
Z-1474-2015
Recall number Z-1474-2015
Initiated January 15, 2015
Classification Class II
Status Terminated
Quantity 6850
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Potential for leaking caused by insufficient bond between needleless device and female luer.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1474-2015
Source locator 0001-device-recall-0001-of-0001.json.zip#results[55500]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential for leaking caused by insufficient bond between needleless device and female luer.
Code information 1311028 1311040 1311041 1407066 1407197 1408055 1409055D 1410048D 1410157D
Distribution pattern Nationwide Distribution including TX, OH, NY, CA, UT, PA, MA, NY, VA, and IL.
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[13011]
FDA event record
· Exact recall-number query on openFDA
device · product 9 of 12
7" Standard Bore High Pressure Ext Set, Product Code: CMS-809 Accessory device used to administer medical fluids
Z-1475-2015
Recall number Z-1475-2015
Initiated January 15, 2015
Classification Class II
Status Terminated
Quantity 6850
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Potential for leaking caused by insufficient bond between needleless device and female luer.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1475-2015
Source locator 0001-device-recall-0001-of-0001.json.zip#results[55502]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential for leaking caused by insufficient bond between needleless device and female luer.
Code information 1311028 1311040 1311041 1407066 1407197 1408055 1409055D 1410048D 1410157D
Distribution pattern Nationwide Distribution including TX, OH, NY, CA, UT, PA, MA, NY, VA, and IL.
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[13832]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1476-2015
Initiated January 15, 2015
Classification Class II
Status Terminated
Quantity 1050
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Potential for leaking caused by insufficient bond between needleless device and female luer.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1476-2015
Source locator 0001-device-recall-0001-of-0001.json.zip#results[49730]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential for leaking caused by insufficient bond between needleless device and female luer.
Code information 1303119 1305010 1306098 1305005
Distribution pattern Nationwide Distribution including TX, OH, NY, CA, UT, PA, MA, NY, VA, and IL.
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[13834]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1477-2015
Initiated January 15, 2015
Classification Class II
Status Terminated
Quantity 2650
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Potential for leaking caused by insufficient bond between needleless device and female luer.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1477-2015
Source locator 0001-device-recall-0001-of-0001.json.zip#results[35787]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential for leaking caused by insufficient bond between needleless device and female luer.
Code information 1303121 1305004 1304149 1305011 1306100 1303122 1304003 1305007 1305006 1305012 1306101
Distribution pattern Nationwide Distribution including TX, OH, NY, CA, UT, PA, MA, NY, VA, and IL.
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[11670]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1478-2015
Initiated January 15, 2015
Classification Class II
Status Terminated
Quantity 1650
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Potential for leaking caused by insufficient bond between needleless device and female luer.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1478-2015
Source locator 0001-device-recall-0001-of-0001.json.zip#results[14798]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential for leaking caused by insufficient bond between needleless device and female luer.
Code information 1310051 1312063
Distribution pattern Nationwide Distribution including TX, OH, NY, CA, UT, PA, MA, NY, VA, and IL.
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[12204]
FDA event record
· Exact recall-number query on openFDA