Z-2101-2015 Class II Terminated
FDA device recall Z-2101-2015 was initiated by Cook Inc. on May 28, 2015 and is designated Class II. 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. The recall status is terminated (terminated May 30, 2017). Affected quantity: 661.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 29, 2015
- Initiation Date
- May 28, 2015
- Termination Date
- May 30, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 661
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.
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.
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.
Code Information
Product Number: KCFW-10.0-35-RB-RTPS-100, Catalog Number G13081
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2101-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026