Churchill Medical Systems, Inc.: Potential for leaking caused by insufficient bond between needleless device and female luer.

Agency Publication Date: April 21, 2015

Affected Products

Product: 6" Trifurcated Extension Set, Product Code: AMS-375-1 Accessory device used to administer medical fluids

1304035, 1407046, 1410111D

Product: Bifircated Extension Set, Product Code: BN-828 Accessory device used to administer medical fluids

1311080

Product: 4" Microbore Double Lumen Set with Bionector, Product Code: BN-208 Accessory device used to administer medical fluids

1303123 1305003 1305008 1305049 1306097

Product: 4" Microbore Trifurcated Ext set, Product Code: BN-308 Accessory device used to administer medical fluids

1303120 1305002 1306099

Product: 4" Microbore T-Port Set, Product Code: BN-448 Accessory device used to administer medical fluids

1303181 1303100 1304183

Product: 8" Standard Bore Ext Set, Product Code: BN-481 Accessory device used to administer medical fluids

1304129 1305051

Product: 7" High Pressure Set with Bionector, Product Code: CMS-808 and CMS-808-1 Accessory device used to administer medical fluids

1303184 1304184 1305112 1306088 1309061 1311057 1312168 1401125 1402017 1403050 1404052 1405018 1405106 1406151 1407065 1408054 1409122D 1410064D 1410155D 1410156D

Product: 7" Standard Bore High Pressure Ext Set, Product Code: CMS-809 Accessory device used to administer medical fluids

1311028 1311040 1311041 1407066 1407197 1408055 1409055D 1410048D 1410157D

Product: 7" Standard Bore High Pressure Ext Set, Product Code: CMS-809 Accessory device used to administer medical fluids

1311028 1311040 1311041 1407066 1407197 1408055 1409055D 1410048D 1410157D

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

1303119 1305010 1306098 1305005

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

1303121 1305004 1304149 1305011 1306100 1303122 1304003 1305007 1305006 1305012 1306101

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

1310051 1312063

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 70369

Status: Resolved

Manufacturer: Churchill Medical Systems, Inc.

Manufactured In: United States

Units Affected: 12 products (5,200; 100; 2350; 2200; 450; 0; 129,500; 6850; 6850; 1050; 2650; 1650)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Product: 6" Trifurcated Extension Set, Product Code: AMS-375-1 Accessory device used to administer medical fluids

1304035, 1407046, 1410111D

Product: Bifircated Extension Set, Product Code: BN-828 Accessory device used to administer medical fluids

1311080

Product: 4" Microbore Double Lumen Set with Bionector, Product Code: BN-208 Accessory device used to administer medical fluids

1303123 1305003 1305008 1305049 1306097

Product: 4" Microbore Trifurcated Ext set, Product Code: BN-308 Accessory device used to administer medical fluids

1303120 1305002 1306099

Product: 4" Microbore T-Port Set, Product Code: BN-448 Accessory device used to administer medical fluids

1303181 1303100 1304183

Product: 8" Standard Bore Ext Set, Product Code: BN-481 Accessory device used to administer medical fluids

1304129 1305051

Product: 7" High Pressure Set with Bionector, Product Code: CMS-808 and CMS-808-1 Accessory device used to administer medical fluids

1303184 1304184 1305112 1306088 1309061 1311057 1312168 1401125 1402017 1403050 1404052 1405018 1405106 1406151 1407065 1408054 1409122D 1410064D 1410155D 1410156D

Product: 7" Standard Bore High Pressure Ext Set, Product Code: CMS-809 Accessory device used to administer medical fluids

1311028 1311040 1311041 1407066 1407197 1408055 1409055D 1410048D 1410157D

Product: 7" Standard Bore High Pressure Ext Set, Product Code: CMS-809 Accessory device used to administer medical fluids

1311028 1311040 1311041 1407066 1407197 1408055 1409055D 1410048D 1410157D

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

1303119 1305010 1306098 1305005

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

1303121 1305004 1304149 1305011 1306100 1303122 1304003 1305007 1305006 1305012 1306101

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

1310051 1312063