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Recall Observatory FDA recall evidence

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

May 28, 2015

Class II

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

    reason.no_named_rule · v1.0.0

    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.

Field note

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