The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2101-2015·Announced 2015-07-29

Cook Inc. Recalls Flexor RTPS Guiding Sheaths Due to Dilator Length Complaints

Cook Inc. is voluntarily recalling Flexor RTPS Guiding Sheaths and Ring Transjugular Intrahepatic Access Sets because users reported the included dilators were 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 classified as FDA Class II and is a voluntary precautionary recall based on complaints about device dimensions (dilators being too long), with no reported injuries or illnesses in the source text.

Plain-English summary

Cook Inc. has initiated a voluntary recall of the Flexor RTPS Guiding Sheaths and the Ring Transjugular Intrahepatic Access Set. The recall is being conducted due to complaints that the dilators included with these devices are too long. The Flexor RTPS Guiding Sheaths are intended for the introduction of balloons, closed and non-tapered end catheters, or other diagnostic and interventional devices.

The recall affects 661 units of the product. The devices were distributed worldwide, including nationwide in the United States and in Canada and the European Union. The specific product number is KCFW-10.0-35-RB-RTPS-100 and the catalog number is G13081.

Healthcare facilities and users should stop using the affected devices and contact Cook Inc. for further instructions on the recall process.

The recalled product

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…
Manufacturer
Cook Inc.
Category
Medical Device — Interventional Catheters
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: KCFW-10.0-35-RB-RTPS-100
  • Catalog Number G13081

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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