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, and the hazard is a potential sterility compromise.
Plain-English summary
Cook Inc. is recalling 10 units of Torcon NB Advantage Catheters. The recall is 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 NS9906241, with reference numbers HNB5.0-38-65-P-2S-C1 and G06827.
The products were distributed worldwide and nationwide in the United States, including specific states and Puerto Rico, as well as in numerous international countries. The source text does not specify what consumers or healthcare providers should do, nor does it report any illnesses or injuries associated with this recall.
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
- 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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