CLASS II Device recall · Reported 20 Mar 2013 · FDA Enforcement Report

Churchill Medical Systems, Inc. A Vygon Company recalled

Vygon is recalling Churchill Medical Systems, Inc. A Vygon Company - All sizes of CMS-CT6T225 6F Triple, distributed in Pennsylvania. The recall was initiated on 17 Dec 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLots numbers MBKQ640, exp 05/2015; MBKZ720, exp 05/2015; MBLJ290, exp 06/2015; MBLR100, exp 07/2015; MBLZ350, exp 09/2015; and MBMG250, exp 10/2015.

Quantity recalled210

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-0937-2013
FDA event ID: 64458
Recalling firm: Vygon, Lansdale, PA
Classification: Class II
Status: Terminated
Recall initiated: 17 Dec 2012
FDA classified: 11 Mar 2013
Reported: 20 Mar 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Heart & Vascular Devices

Timeline

17 Dec 2012	Recall initiated by company
11 Mar 2013	Classified by FDA	+84 days
20 Mar 2013	Published in enforcement report	+9 days

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

Reason for recall

Product was packaged with the incorrect introducer needle. The kit label indicates a "safety" needle is included; the kits were packaged with a non-safety needle.

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

Churchill Medical Systems, Inc. A Vygon Company - All sizes of CMS-CT6T225 6F Triple Lumen CT PICC with M.S.T. Components, Peripherally Inserted Central Catheter.

Where it was distributed

Product was distributed to 4 hospitals (under one hospital network) within the State of Pennsylvania

Pennsylvania

Questions about this recall

Why was it recalled?

Product was packaged with the incorrect introducer needle. The kit label indicates a "safety" needle is included; the kits were packaged with a non-safety needle.

Which lots are affected?

Lots numbers MBKQ640, exp 05/2015; MBKZ720, exp 05/2015; MBLJ290, exp 06/2015; MBLR100, exp 07/2015; MBLZ350, exp 09/2015; and MBMG250, exp 10/2015.

Where was it sold?

Product was distributed to 4 hospitals (under one hospital network) within the State of Pennsylvania

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 Vygon

All 14

Reported	Class	Recall	Company	Reason	Where
29 Oct 2014Device	CLASS II	Bionector Needleless connector recalled by Vygon	Vygon	Other	CA
20 Jun 2012Device	CLASS II	VY(TM)Flush Heparin Lock Flush Syringes per mL recalled by Vygon	Vygon	Other	Nationwide
20 Jun 2012Device	CLASS II	Churchill Medical Systems, Inc. Vad Access Tray Kit recalled by Vygon	Vygon	Other	Nationwide
20 Jun 2012Device	CLASS II	VY(TM)Flush Heparin Lock Flush Syringes per mL recalled by Vygon	Vygon	Other	Nationwide
20 Jun 2012Device	CLASS II	Churchill Medical Systems, Inc. Dressing Change Kit recalled by Vygon	Vygon	Other	Nationwide

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