CLASS II Device recall · Reported 29 Apr 2015 · FDA Enforcement Report

Bifurcated set with check vales and Bionectors, Product recalled

Churchill Medical Systems is recalling Bifurcated set with check vales and Bionectors, distributed nationwide in the US. The recall was initiated on 15 Jan 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1303119 1305010 1306098 1305005

Quantity recalled1050

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1476-2015
FDA event ID: 70369
Recalling firm: Churchill Medical Systems, Dover, NH
Classification: Class II
Status: Terminated
Recall initiated: 15 Jan 2015
FDA classified: 21 Apr 2015
Reported: 29 Apr 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

15 Jan 2015	Recall initiated by company
21 Apr 2015	Classified by FDA	+96 days
29 Apr 2015	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Potential for leaking caused by insufficient bond between needleless device and female luer.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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

Where it was distributed

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

Nationwide California Illinois Massachusetts New York Ohio Pennsylvania Texas Utah Virginia

Questions about this recall

Why was it recalled?

Potential for leaking caused by insufficient bond between needleless device and female luer.

Which lots are affected?

1303119 1305010 1306098 1305005

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

11 other products · FDA event 70369

This product is part of a recall event; the main page for the event is 4" Trifurcated set with Bionectors and check valves, Product recalled.

Reported	Class	Recall	Company	Reason	Where
29 Apr 2015	CLASS II	4" Trifurcated set with Bionectors and check valves, Product recalled	Churchill Medical Systems	Packaging Defects	Nationwide
29 Apr 2015	CLASS II	4" Microbore T-Port Set, Product recalled by Churchill Medical Systems	Churchill Medical Systems	Packaging Defects	Nationwide
29 Apr 2015	CLASS II	4" Microbore Trifurcated Ext set, Product recalled	Churchill Medical Systems	Packaging Defects	Nationwide
29 Apr 2015	CLASS II	6" Trifurcated set with Bionectors, Product recalled	Churchill Medical Systems	Packaging Defects	Nationwide
29 Apr 2015	CLASS II	7" Standard Bore High Pressure Ext Set, Product recalled	Churchill Medical Systems	Packaging Defects	Nationwide
29 Apr 2015	CLASS II	4" Microbore Double Lumen Set with Bionector, Product recalled	Churchill Medical Systems	Packaging Defects	Nationwide
29 Apr 2015	CLASS II	6" Trifurcated Extension Set, Product recalled	Churchill Medical Systems	Packaging Defects	Nationwide
29 Apr 2015	CLASS II	7" High Pressure Set with Bionector, Product recalled	Churchill Medical Systems	Packaging Defects	Nationwide
29 Apr 2015	CLASS II	8" Standard Bore Ext Set, Product recalled by Churchill Medical Systems	Churchill Medical Systems	Packaging Defects	Nationwide
29 Apr 2015	CLASS II	7" Standard Bore High Pressure Ext Set, Product recalled	Churchill Medical Systems	Packaging Defects	Nationwide
29 Apr 2015	CLASS II	Bifircated Extension Set, Product recalled by Churchill Medical Systems	Churchill Medical Systems	Packaging Defects	Nationwide

More recalls from Churchill Medical Systems

All 16

Reported	Class	Recall	Company	Reason	Where
29 Apr 2015Device	CLASS II	Bifircated Extension Set, Product recalled by Churchill Medical Systems	Churchill Medical Systems	Packaging Defects	Nationwide
29 Apr 2015Device	CLASS II	7" Standard Bore High Pressure Ext Set, Product recalled	Churchill Medical Systems	Packaging Defects	Nationwide
29 Apr 2015Device	CLASS II	8" Standard Bore Ext Set, Product recalled by Churchill Medical Systems	Churchill Medical Systems	Packaging Defects	Nationwide
29 Apr 2015Device	CLASS II	7" High Pressure Set with Bionector, Product recalled	Churchill Medical Systems	Packaging Defects	Nationwide
29 Apr 2015Device	CLASS II	6" Trifurcated Extension Set, Product recalled	Churchill Medical Systems	Packaging Defects	Nationwide

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