Agency classClass IIOur severity:High FDA (Devices)·Z-0441-2020·Announced 2019-11-27

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

Cook Inc. is recalling 425 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 in a medical device) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Cook Inc. is recalling 425 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 was initiated due to the potential compromise of the sterility of the products. This issue is attributed to an undersealed chevron in the packaging pouches. The affected units were distributed worldwide, including in the United States and various international countries.

Physicians and healthcare facilities should stop using the affected catheters and contact Cook Inc. for further instructions. The specific lot numbers and UDI codes for the recalled units are listed in the official FDA recall notice.

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: 425

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 (19)

REF (RPN): HNB5.0-38-100-P-10S-PIG REF (GPN): G06227 Lot Numbers: 9694590
9700380
9700381
9700765
9703643
9703644
9703645
9703646
9711281
9711282 UDIs: (01)00827002062276(17)220508(10)9694590
(01)00827002062276(17)220510(10)9700380
(01)00827002062276(17)220508(10)9700381
(01)00827002062276(17)220509(10)9700765
(01)00827002062276(17)220513(10)9703643
(01)00827002062276(17)220513(10)9703644
(01)00827002062276(17)220510(10)9703645
(01)00827002062276(17)220510(10)9703646
(01)00827002062276(17)220515(10)9711281
(01)00827002062276(17)220516(10)9711282

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