Device product
Ring Transjugular Intrahepatic Access Set Product Usage: The Ring Transjugular Intrahepatic Access Sets are intended for transjugular liver access in diagnostic and interventional procedures. The Ring Transjugular Intrahepatic Access Set consists of the following components: Flexor RTPS Guiding Sheath, needle, catheter, Dilator, Torcon NB Advantage Catheter, Van Andel Dilatation Catheter, Curved Newton Wire Guide, Amplatz Extra Stiff Wire Guide.
Z-2100-2015
Product summary
- Firm
- Cook Inc.
- Event
- Event 71430
- Status
- Terminated
- Classification
- Class II
- Quantity
- 661
- Official record key
device-enforcement:Z-2100-2015
Official wording
Reason: 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.
Code information: Product Number: RTPS-100-10.0, Catalog Number G29769
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.
Derived failure modes
-
Unknown
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.