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

Flexor RTPS Guiding Sheath recalled by Cook

Cook is recalling Flexor RTPS Guiding Sheath, distributed nationwide in the US. The recall was initiated on 28 May 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Number: KCFW-10.0-35-RB-RTPS-100, Catalog Number G13081

Quantity recalled661

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-2101-2015
FDA event ID: 71430
Recalling firm: Cook, Bloomington, IN
Classification: Class II
Status: Terminated
Recall initiated: 28 May 2015
FDA classified: 17 Jul 2015
Reported: 29 Jul 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Device type: Heart & Vascular Devices

Timeline

28 May 2015	Recall initiated by company
17 Jul 2015	Classified by FDA	+50 days
29 Jul 2015	Published in enforcement report	+12 days

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

Reason for recall

Cook Inc. is initiating a voluntary recall of the Ring Transjugular Intrahepatic Access Set and the Flexor RTPS Introduce Sheath due to complaints of the dilators being too long.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

Flexor RTPS Guiding Sheath Product Usage: The Flexor RTPS Guiding Sheaths are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices. These curved sheaths are manufactured from material incorporating a stainless steel wire imbedded in the sheath shaft material with a soft tip and a Check-Flo¿ fitting at the proximal end. The sheath is accompanied by a dilator for access to the body as a catheter over the wire guide.

Where it was distributed

Worldwide Distribution - US Nationwide in the state of: AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NM, NV, NY, OH, OK, PA, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Canada and EU.

Nationwide Arkansas Arizona California Colorado Connecticut District of Columbia Florida Georgia Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Michigan Minnesota Missouri North Carolina Nebraska

Questions about this recall

Is Flexor RTPS Guiding Sheath recalled?

Yes. Cook recalled Flexor RTPS Guiding Sheath on 28 May 2015. The recall is Class II and its status is Terminated. Recall number Z-2101-2015.

Why was it recalled?

Cook Inc. is initiating a voluntary recall of the Ring Transjugular Intrahepatic Access Set and the Flexor RTPS Introduce Sheath due to complaints of the dilators being too long.

Which lots are affected?

Product Number: KCFW-10.0-35-RB-RTPS-100, Catalog Number G13081

Where was it sold?

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.

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