CLASS II Device recall · Reported 20 Jun 2012 · FDA Enforcement Report

Churchill Medical Systems, Inc. Dressing Change Kit recalled by Vygon

Vygon is recalling Churchill Medical Systems, Inc. Dressing Change Kit Prefilled syringes included in the, distributed nationwide in the US. The recall was initiated on 11 May 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Code AMS-7091CP - lot 11C119.

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-1807-2012
FDA event ID: 61945
Recalling firm: Vygon, Montgomeryville, PA
Classification: Class II
Status: Terminated
Recall initiated: 11 May 2012
FDA classified: 13 Jun 2012
Reported: 20 Jun 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

11 May 2012	Recall initiated by company
13 Jun 2012	Classified by FDA	+33 days
20 Jun 2012	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

Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes.

Product as listed by the FDA

Churchill Medical Systems, Inc. DRESSING CHANGE KIT Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens

Where it was distributed

Nationwide Distribution including AZ, CA, DE, FL, IL, IN, IA, KS, KY, MD, MA, MI, MN, MO, NJ, NY, OH, PA, UT, VA, WA, WV, and WI.

Nationwide Arizona California Delaware Florida Iowa Illinois Indiana Kansas Kentucky Massachusetts Maryland Michigan Minnesota Missouri New Jersey New York Ohio Pennsylvania Utah Virginia

Questions about this recall

Is Churchill Medical Systems, Inc. Dressing Change Kit Prefilled syringes included in the recalled?

Yes. Vygon recalled Churchill Medical Systems, Inc. Dressing Change Kit Prefilled syringes included in the on 11 May 2012. The recall is Class II and its status is Terminated. Recall number Z-1807-2012.

Why was it recalled?

Which lots are affected?

Product Code AMS-7091CP - lot 11C119.

Where was it sold?

Nationwide Distribution including AZ, CA, DE, FL, IL, IN, IA, KS, KY, MD, MA, MI, MN, MO, NJ, NY, OH, PA, UT, VA, WA, WV, and WI.

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 Vygon

All 14

Reported	Class	Recall	Company	Reason	Where
29 Oct 2014Device	CLASS II	Bionector Needleless connector recalled by Vygon	Vygon	Other	Nationwide
20 Mar 2013Device	CLASS II	Churchill Medical Systems, Inc. A Vygon Company recalled	Vygon	Packaging Defects	PA
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

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