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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 70369

12 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

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

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.

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

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

1311080

Distribution pattern

Nationwide Distribution including TX, OH, NY, CA, UT, PA, MA, NY, VA, and IL.

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

device · product 10 of 12

Bifurcated set with check vales and Bionectors, Product Code: BN-2082CV Accessory device used to administer medical fluids

Z-1476-2015
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

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.

device · product 11 of 12

4" Trifurcated set with Bionectors and check valves, Product Code: BN-3082CV and BN-3083CV Accessory device used to administer medical fluids

Z-1477-2015
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

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.

device · product 12 of 12

6" Trifurcated set with Bionectors, Product Code: BN-944 Accessory device used to administer medical fluids

Z-1478-2015
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

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.