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Recall Observatory FDA recall evidence

Device 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.

Z-2101-2015

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-2101-2015

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: KCFW-10.0-35-RB-RTPS-100, Catalog Number G13081

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.