Cook Inc.: 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.

Agency Publication Date: July 18, 2015

Affected Products

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.

Product Number: RTPS-100-10.0, Catalog Number G29769

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.

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

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 71430

Status: Resolved

Manufacturer: Cook Inc.

Manufactured In: United States

Units Affected: 2 products (661)

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Sources: FDA iRES · Raw API Response

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Affected Products

Product Number: RTPS-100-10.0, Catalog Number G29769

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