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 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 risk-of-harm product (medical device) where sterility may be compromised, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Cook Inc. is recalling Torcon NB Advantage Catheters due to a potential compromise of sterility. The issue stems from undersealed chevron in the packaging pouches, which may allow contamination of the medical devices.
The affected products are intended for use in the peripheral and coronary vascular system, including the carotid arteries, in angiographic procedures. The recall includes 5 units with Lot Number NS9717356. These products were distributed nationwide in the United States and in various countries worldwide, including Australia, Belgium, Canada, China, and the United Kingdom.
Healthcare providers and facilities should stop using the affected catheters and contact Cook Inc. for further instructions. Consumers are not expected to have these products in their homes, as they are medical devices used by trained physicians.
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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