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 worldwide and across the US.
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. The hazard involves a risk of harm (loss of sterility) in a medical device, but the source text does not report any illnesses or injuries, fitting the criteria for a High severity score.
Plain-English summary
Cook Inc. is recalling Torcon NB Advantage Catheters due to a potential compromise of sterility. The issue stems from undersealed chevron packaging pouches, which may allow the products to lose their sterile status.
The affected product is intended for use in the peripheral and coronary vascular system, including the carotid arteries, in angiographic procedures. The recall involves 5 units with Lot Number NS9913494. These products were distributed worldwide and in the United States, including specific states and territories listed in the agency notice.
Healthcare providers and facilities should stop using the affected catheters and contact Cook Inc. for further instructions. Consumers should not use these medical devices if they have them in their possession.
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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