Agency classClass IIOur severity:High FDA (Devices)·Z-0434-2020·Announced 2019-11-27

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

Cook Inc. is recalling 405 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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a potential sterility compromise in a medical device used in invasive procedures. While no specific injuries are reported in the text, the risk of infection from non-sterile devices in vascular systems represents a significant health hazard, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Cook Inc. is recalling 405 units of Torcon NB Advantage Catheters. These medical devices are intended for use in the peripheral and coronary vascular system, including the carotid arteries, in angiographic procedures by trained physicians.

The recall is due to a potential compromise of the sterility of the products. The issue stems from undersealed chevron in the packaging pouches, which may allow contamination.

The affected units were distributed worldwide, including in the United States and various international countries. Specific lot numbers and UDI codes are listed in the recall documentation. Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected devices.

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
infection-risk
Affected units: 405

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 (9)

REF (RPN): HNB5.0-38-100-P-NS-SIM2 REF (GPN): G05976 Lot Numbers: 9700386
9701378
9707469
9710399
9713002 UDIs: (01)00827002059764(17)220511(10)9700386
(01)00827002059764(17)220510(10)9701378
(01)00827002059764(17)220514(10)9707469
(01)00827002059764(17)220510(10)9710399
(01)00827002059764(17)220516(10)9713002

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