Cook Inc.: Medical Device Recall in 2015 - (Recall #: Z-2101-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: May 28, 2015

Date Posted: July 29, 2015

Recall Number: Z-2101-2015

Event ID: 71430

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.

Status: Terminated

Product Quantity: 661

Code Information:

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

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated