Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0477-2020·Announced 2019-11-27

Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

Cook Inc. is recalling 135 Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The devices are distributed worldwide.

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. The hazard is a potential sterility compromise due to packaging defects, which is a low-risk contamination issue without reported illnesses or injuries, fitting the criteria for a moderate severity score.

Plain-English summary

Cook Inc. is recalling 135 units of Torcon NB Advantage Catheters. The recall is due to a potential compromise of the sterility of the products caused by an undersealed chevron in the packaging pouches.

These catheters are intended for use in the peripheral and coronary vascular system, including the carotid arteries, in angiographic procedures by physicians trained and experienced in angiographic techniques. The affected units are identified by Lot Numbers 9714956 and 9719147, with Reference Numbers HNB5.0-38-100-P-NS-JR3 and G10930.

The products were distributed worldwide, including nationwide in the United States and in numerous international countries. No specific instructions for consumers or healthcare providers are provided in the source text.

The recalled product

Product: Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
Manufacturer: Cook Inc.
Category: Medical Device — Catheters
Hazard: sterility-compromise
packaging-defect
Affected units: 135

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 (3)

REF (RPN): HNB5.0-38-100-P-NS-JR3 REF (GPN): G10930 Lot Numbers: 9714956
9719147 UDIs: (01)00827002109308(17)220516(10)9714956
(01)00827002109308(17)220513(10)9719147

Distribution

Distributed nationwide across the United States.

The notice also names 39 states specifically:

Part of a larger recall action

This product is one of 71 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 71 products in this recall →

Same manufacturer · Cook Inc.

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Same hazard · sterility compromise