The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2100-2015·Announced 2015-07-29

Cook Inc. Recalls Ring Transjugular Intrahepatic Access Set Due to Dilator Length

Cook Inc. is voluntarily recalling 661 Ring Transjugular Intrahepatic Access Sets and Flexor RTPS Introduce Sheaths because the dilators are too long.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is a voluntary precautionary action initiated due to complaints about component dimensions (dilators being too long), with no reported injuries or illnesses in the source text.

Plain-English summary

Cook Inc. is initiating a voluntary recall of the Ring Transjugular Intrahepatic Access Set and the Flexor RTPS Introduce Sheath. The recall is due to complaints that the dilators included in the sets are too long. The product is intended for transjugular liver access in diagnostic and interventional procedures.

The recall involves 661 units of the Ring Transjugular Intrahepatic Access Set, identified by Product Number RTPS-100-10.0 and Catalog Number G29769. The set consists of the Flexor RTPS Guiding Sheath, needle, catheter, Dilator, Torcon NB Advantage Catheter, Van Andel Dilatation Catheter, Curved Newton Wire Guide, and Amplatz Extra Stiff Wire Guide.

The affected products were distributed worldwide, including nationwide in the United States and in Canada and the EU. Healthcare providers and facilities should stop using the affected products and contact Cook Inc. for further instructions.

The recalled product

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…
Manufacturer
Cook Inc.
Category
Medical Device — Interventional Radiology
Hazard
Affected units
661

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

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

Distribution

Distributed nationwide across the United States.

The notice also names 35 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Cook Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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