Z-2101-2015Class II

Flexor RTPS Guiding Sheath

Name: Z-2101-2015 Flexor RTPS Guiding Sheath
Creator: Cook Inc.
Published: 2015-05-28
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2015-05-28 / Terminated

FDA source

Cook Inc. began a recall of Flexor RTPS Guiding Sheath Product Usage: The Flexor RTPS Guiding Sheaths are intended for introduction of balloons, closed and non-tapered end catheters or... on 2015-05-28. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2101-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-28
Posted: 2015-07-18
Terminated: 2017-05-30
Recalling firm: Cook Incorporated
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.
Product code: DYB Introducer, Catheter
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.
FDA root cause: Component change control
Action: 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.
Quantity in commerce: 661
Distribution: 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.
Product codes and lots: Product Number: KCFW-10.0-35-RB-RTPS-100, Catalog Number G13081

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2101-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2100-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-17
Z-2101-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-17

Product code DYB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)