CLASS II Device recall · Reported 25 Sep 2013 · FDA Enforcement Report

Vygon 14 Microbore Extension Set with Bionector, CMS recalled

Churchill Medical Systems is recalling Vygon 14 Microbore Extension Set with Bionector, CMS-814-1, distributed nationwide in the US. The recall was initiated on 12 Aug 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1203117, 1206030, 1212111, 1304133, 130516

Quantity recalled13100

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-2251-2013
FDA event ID: 66060
Recalling firm: Churchill Medical Systems, Dover, NH
Classification: Class II
Status: Terminated
Recall initiated: 12 Aug 2013
FDA classified: 18 Sep 2013
Reported: 25 Sep 2013
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

12 Aug 2013	Recall initiated by company
18 Sep 2013	Classified by FDA	+37 days
25 Sep 2013	Published in enforcement report	+7 days

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

Reason for recall

Microbore tubing disconnecting from male luers on the extension sets.

Product as listed by the FDA

Vygon 14 Microbore Extension Set with Bionector, CMS-814-1. The CMS-814-1 is a 14 inch extension set used to administer IV fluids.

Where it was distributed

Nationwide Distribution (US), including the states of NY, MN, NJ, PA, FL, MD, and VA.

Nationwide Florida Maryland Minnesota New Jersey New York Pennsylvania Virginia

Questions about this recall

Why was it recalled?

Microbore tubing disconnecting from male luers on the extension sets.

Which lots are affected?

1203117, 1206030, 1212111, 1304133, 130516

Where was it sold?

Nationwide Distribution (US), including the states of NY, MN, NJ, PA, FL, MD, and VA.

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

1 other product · FDA event 66060

Reported	Class	Recall	Company	Reason	Where
25 Sep 2013	CLASS II	Central Dressing Change Kit recalled by Churchill Medical Systems	Churchill Medical Systems	Other	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	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

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide