Cook Inc. Recalls Torcon NB Advantage Catheters Due to Packaging Seal Defect
Cook Inc. is recalling 95 Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The devices were distributed worldwide.
What this means for you
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 is classified as FDA Class II and involves a risk of harm (sterility compromise) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Cook Inc. is recalling 95 units of Torcon NB Advantage Catheters. The recall was initiated due to a potential compromise of the sterility of the products caused by an undersealed chevron in the packaging pouches.
The affected 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 specific lot number is 9712522, with Reference Number HNB5.0-38-100-P-NS-VTK and Global Product Number G10756.
The devices were distributed worldwide, including nationwide in the United States and in various countries such as Australia, Belgium, Canada, China, and the United Kingdom. No specific instructions for consumers are provided in the source text, but the recall is classified as Class II by the FDA.
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
- 95
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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