—#138148

Product

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.

FDA product code: DYB — Introducer, Catheter
Device class: Class 2
Medical specialty: Cardiovascular
Affected lot / code info: Product Number: KCFW-10.0-35-RB-RTPS-100, Catalog Number G13081

Why it was 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.

Root cause (FDA determination)

Component change control

Action the firm took

Written recall communication letters were shipped via FedEx on June 05, 2015 to all US Consignees. Customers were asked to complete and return response forms and recalled products. Recalled devices will be held for final disposition and destruction. Customers wree asked to forward notices if recalled devices were further distributed. Effectivenes checks will be conducted by mail, phone and visits. Customers may contact Cook Medical Relations (800) 457-4500 or 1 (812)- 339-2235 Monday through Friday from 7:30 AM to 5:00 PM or e-mail at CustomerrelationsNA@cook medical.com.

Recalling firm

Firm: Cook Inc.
Address: 750 N Daniels Way, Bloomington, Indiana 47404-9120

Distribution

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.

Timeline

Recall initiated: 2015-05-28
Posted by FDA: 2015-07-18
Terminated: 2017-05-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #138148. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.