Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns
Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The recall covers units distributed worldwide and across the US.
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 (medical device) where sterility compromise could lead to infection, but no injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for theoretical risk without reported harm.
Plain-English summary
Cook Inc. is recalling five units of Torcon NB Advantage Catheters due to a potential compromise of sterility. The issue stems from undersealed chevron packaging pouches, which may allow contamination of the medical devices.
The affected catheters are intended for use in the peripheral and coronary vascular system, including the carotid arteries, in angiographic procedures by trained physicians. The specific lot number is 9903996, with Reference Number HNB5.0-38-65-P-NS-TC-01 and Global Procedure Number G47192.
The recall covers units distributed worldwide and nationwide in the United States, including specific states and territories listed in the agency notice. Healthcare facilities and distributors should stop using the affected units and contact Cook Inc. for further instructions.
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
- Affected units
- 5
Distribution
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.
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