Cook Torcon NB Advantage Catheters Recalled for Potential Sterility Compromise
Cook Inc. is recalling Torcon NB Advantage Catheters due to potential sterility compromise from undersealed packaging pouches.
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 risk-of-harm product (medical device) where injury has not yet been reported, fitting the High severity criteria for potential sterility compromise.
Plain-English summary
Cook Inc. is recalling Torcon NB Advantage Catheters because of a potential compromise of the sterility of the products. The issue stems from undersealed chevron in the packaging pouches.
The affected products 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 involves 5 units distributed worldwide and nationwide in the United States, including specific states and Puerto Rico, as well as in numerous international countries.
Healthcare providers and facilities should stop using the affected catheters and contact Cook Inc. for further instructions. The specific lot number is NS9928939, with Reference Number HNB5.0-38-75-P-NS-C1 and GPN G27702.
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
- 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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