Agency classClass IIOur severity:High FDA (Devices)·Z-0429-2020·Announced 2019-11-27

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

Cook Inc. is recalling 585 Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The devices were 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, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.

Plain-English summary

Cook Inc. is recalling 585 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 were distributed worldwide, including in the United States and various international countries.

Healthcare providers should stop using the affected catheters and contact Cook Inc. for instructions on return or replacement. Patients who have received these devices should contact their healthcare provider for guidance.

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: 585

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 (13)

REF (RPN): HNB5.0-38-100-P-NS-JL3.5 REF (GPN): G05924 Lot Numbers: 9705826
9707669
9709326
9714955
9716791
9717961
NS9718543 UDIs: (01)00827002059245(17)220516(10)9705826
(01)00827002059245(17)220513(10)9707669
(01)00827002059245(17)220515(10)9709326
(01)00827002059245(17)220516(10)9714955
(01)00827002059245(17)220510(10)9716791
(01)00827002059245(17)220511(10)9717961
(01)00827002059245(17)220516(10)NS9718543

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