CLASS II Device recall · Reported 29 Jan 2014 · FDA Enforcement Report

AMS-530 7 Microbore Trifurcated Extension sets recalled

Churchill Medical Systems is recalling AMS-530 7 Microbore Trifurcated Extension sets, distributed nationwide in the US. The recall was initiated on 7 Jan 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number: 1306034, 1307011

Quantity recalled3850

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-0813-2014
FDA event ID: 67255
Recalling firm: Churchill Medical Systems, Dover, NH
Classification: Class II
Status: Terminated
Recall initiated: 7 Jan 2014
FDA classified: 23 Jan 2014
Reported: 29 Jan 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Heart & Vascular Devices

Timeline

7 Jan 2014	Recall initiated by company
23 Jan 2014	Classified by FDA	+16 days
29 Jan 2014	Published in enforcement report	+6 days

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

Reason for recall

Defective component may cause extension sets to leak.

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

AMS-530 7 Microbore Trifurcated Extension sets Product Usage: Intravascular administration set.

Where it was distributed

US Nationwide Distribution in the states of: NY, VA, IL, MO, OR, FL, DE, OH

Nationwide Delaware Florida Illinois Missouri New York Ohio Oregon Virginia

Questions about this recall

Why was it recalled?

Defective component may cause extension sets to leak.

Which lots are affected?

Lot Number: 1306034, 1307011

Where was it sold?

US Nationwide Distribution in the states of: NY, VA, IL, MO, OR, FL, DE, OH

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.

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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