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U.S. Department of Health and Human Services

Class 2 Device Recall Flexor RTPS Guiding Sheath

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  Class 2 Device Recall Flexor RTPS Guiding Sheath see related information
Date Initiated by Firm May 28, 2015
Date Posted July 18, 2015
Recall Status1 Terminated 3 on May 30, 2017
Recall Number Z-2101-2015
Recall Event ID 71430
Product Classification Introducer, catheter - Product Code DYB
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.
Code Information Product Number: KCFW-10.0-35-RB-RTPS-100, Catalog Number G13081
Recalling Firm/
Manufacturer		 Cook Inc.
750 N Daniels Way
Bloomington IN 47404-9120
For Additional Information Contact Cook Medical Customer Relations Departme
812-339-2235
Manufacturer 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 Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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