Agency classClass IIOur severity:High FDA (Devices)·Z-0432-2020·Announced 2019-11-27

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

Cook Inc. is recalling 1,125 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 risk-of-harm product (sterility compromise) where injury has not yet been reported, which aligns with the High severity criteria.

Plain-English summary

Cook Inc. is recalling 1,125 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 physicians trained and experienced in angiographic techniques.

The recall is due to the potential compromise of the sterility of the products. This issue is caused by an undersealed chevron in the packaging pouches. The affected lot numbers are 9916981, 9924484, 9924486, 9943478, 9943643, 9943644, 9944133, 9946873, 9946875, 9947569, 9949557, 9949558, 9952694, and NS9938577.

The products were distributed worldwide, including in the United States and various international countries. The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled 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
Affected units: 1,125

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 (20)

REF (RPN): HNB5.0-38-80-P-NS-C2 REF (GPN): G05955 Lot Numbers: 9916981
9924484
9924486
9943478
9943643
9943644
9944133
9946873
9946875
9947569
9949557
9949558
9952694
NS9938577 UDIs: (01)00827002059559(17)220805(10)9916981
(01)00827002059559(17)220807(10)9924484
(01)00827002059559(17)220807(10)9924486
(01)00827002059559(17)220823(10)9943478
(01)00827002059559(17)220822(10)9943643
(01)00827002059559(17)220822(10)9943644
(01)00827002059559(17)220822(10)9944133

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