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

4" Microbore Trifurcated Ext set, Product recalled

Churchill Medical Systems is recalling 4" Microbore Trifurcated Ext set, Product, 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 codes1303120 1305002 1306099

Quantity recalled2200

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-1470-2015
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

4" Microbore Trifurcated Ext set, Product Code: BN-308 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

Is 4" Microbore Trifurcated Ext set, Product recalled?

Yes. Churchill Medical Systems recalled 4" Microbore Trifurcated Ext set, Product on 15 Jan 2015. The recall is Class II and its status is Terminated. Recall number Z-1470-2015.

Why was it recalled?

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

Which lots are affected?

1303120 1305002 1306099

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

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	Bifurcated set with check vales and Bionectors, 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

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