Cook Inc. Recalls Torcon NB Advantage Catheters Due to Packaging Seal Issues
Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The recall covers units distributed in the US and internationally.
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 involves a potential sterility compromise in a medical device used in vascular procedures, which presents 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 10 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 NS9939355, and the Reference Number (RPN) is HNB5.0-38-80-P-NS-RIM.
The products were distributed worldwide, including in the United States and various international countries. Healthcare providers and facilities should check their inventory for the specific lot number and stop using the affected devices if found.
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
- 10
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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